Berkley and Jensen Acid Reducer Maximum Strength FDA Alerts

FDA Requests Removal of All Ranitidine Products (Zantac) From the Market

ISSUE:  The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. 

This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen (a substance that could cause cancer). FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

BACKGROUND: Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

RECOMMENDATION:

• Consumers: The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.
• Patients: Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
• Consumers and Patients: In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the FDA’s recommended steps which include ways to safely dispose of these medications at home.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online 
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form or submit by fax to 1-800-FDA-0178

American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

February 27, 2020 -- American Health Packaging has voluntarily recalled eleven (11) lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters to the consumer level due to the potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. This recall was initiated in response to the recall by the manufacturer (Amneal Pharmaceuticals, LLC), which included affected lots that were repackaged by American Health Packaging.

Risk Statement: NDMA is classified as a probable human carcinogen, a substance that can cause cancer, based on laboratory testing. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy and vegetables. No reports of injury or adverse events to date.

Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis.

American Health Packaging has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Product was distributed Nationwide to Wholesalers for use in hospital settings.

American Health Packaging has notified its distributors by recall letter, sent November 20th, 2019, to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. American Health Packaging has arranged for return of all recalled products to lnmar Pharmaceuticals Services. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Instructions for returning recalled products are given in the recall letter. Pharmacies that have received the affected lot should contact (877) 475-5864 to receive a return packet. Hours of operation are 9:00 am - 5:00 pm, Eastern Standard Time (EST) Monday thru Friday.

Any general questions regarding the return of this product please contact Inmar Pharmaceuticals Services at 800-967-5952 (option 1). Hours of operation are 9:00 am - 5:00 pm, EST Monday through Friday.

Consumers who have Ranitidine Tablets, USP which are being recalled should stop using the product or with questions regarding this recall can contact Inmar Pharmaceuticals Services by 800-967-5952 (option 1). Hours of operation are 9:00 am - 5:00 pm, EST Monday through Friday.

Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-Nitrosodimethylamine (NDMA) Impurity

January 8, 2020 -- Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. The recall is in response to the manufacturer’s recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, which were repackaged by Denton Pharma, Inc. dba Northwind Pharmaceuticals. To date, Northwind has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables.

The Ranitidine Tablets, USP, distributed by Northwind are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

The Ranitidine Tablets, USP, subject to the recall can be identified by the NDC number on the product label. The following NDCs of Ranitidine Tablets, USP, 150 mg and 300 mg, are included in this recall:

The affected Ranitidine Tablets were distributed directly to Northwind Pharmaceuticals, LLC and Crosswind Pharmacy.

The 150mg products product are packaged in unit of use bottle packs of 4’s, 20’s, 24’s, 30’s, and 90’s, whereas, the 300mg product are packaged in unit of use bottle packs of 15’s and 90’s. Photos are attached below.

Northwind is notifying its direct customers with a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lot immediately. Northwind is committed to product and consumer safety. It will continue to fully cooperate with the FDA as the agency evaluates ranitidine products for the presence of NDMA above established limits and formulates guidance for ranitidine manufacturers. As a further precautionary measure, Northwind ceased distribution of its Ranitidine products in the United States while the manufacturer continues its efforts to test and investigate in cooperation with the FDA.

Customers who purchased the impacted product directly from Northwind can call Northwind at 1-800-722-0772 Monday – Friday, 9:00 am – 5:00 pm, EST to arrange for product return.

Consumers who have Ranitidine Tablets, USP subject to this recall should immediately discontinue use, discard remaining product and consult with their physician or healthcare provider about treatment options.

Consumers who would like to report any adverse reactions or quality problems experienced as a result of their use of this product, or have questions regarding the use of Ranitidine Tablets, USP can contact Northwind at 1-800-722-0772 Monday – Friday, 9:00 am – 5:00 pm, EST.

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

January 07, 2020 -- Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. To date, Appco has not received any reports of adverse events related to use of the product as part of this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine Hydrochloride in strengths of 150 mg and 300 mg, is a prescription-only oral medication indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable.

The products subject to recall are listed below and are packaged in bottles. The product can be identified by checking the product name, count/bottle, manufacturer details and batch or lot number on the bottle containing these products.

Ranitidine Capsules 150 mg & Ranitidine Capsules 300 mg were distributed nationwide.

Appco is notifying their marketing partner (ANI Pharmaceuticals, Inc.) by phone, email or other communication with recall notification communication. ANI Pharmaceuticals Inc., on behalf of Appco Pharma LLC, will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Appco is arranging for return of all recalled products to ANI Pharmaceuticals, Inc. Instructions for returning recalled products are given in the recall letter. Anyone with an existing inventory will be asked to immediately stop distribution and return any stock to ANI Pharmaceuticals, Inc. by contacting Stephen Bitter at stephen.bitter@anipharmaceuticals.com or 218-634-3655 (between 8 to 5PM CST). All the recalled product shall be sent to:

Consumers that have product which is being recalled should stop using/return to place of purchase and speak to their physician or pharmacist about alternate healthcare treatment options.

Consumers with questions regarding this recall can contact Appco at: (732) 253-7735 between 8 am and 6 pm (EST) (Monday-Friday) or e-mail: pv@appcopharma.com or at ANI Pharmaceuticals, Inc. at 1-800-308-6755 or PVSupport@safetycall.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

December 17, 2019 -- Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level.

The recalled lots of Ranitidine Tablets 150 mg and 300 mg, which are listed in Attachment B, are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables.

Glenmark’s Ranitidine Tablets 150 mg and 300 mg are manufactured at two approved manufacturing facilities. Of the 928 recalled lots of Ranitidine Tablets, USP, 16 lots were manufactured by Glenmark Pharmaceuticals Ltd., Goa, India and 912 lots were manufactured by Strides Pharma Science Limited, Puducherry, India. Ranitidine Tablets 150 mg and 300 mg is a prescription oral product approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

Glenmark is committed to product and consumer safety. It will continue to fully cooperate with the FDA as the agency evaluates ranitidine products for the presence of NDMA above established limits and formulates guidance for ranitidine manufacturers. As a further precautionary measure, Glenmark ceased distribution of its Ranitidine products in the United States while it continues its efforts to test and investigate in cooperation with the FDA.

To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall. The Ranitidine Tablets, USP, distributed by Glenmark are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

The Ranitidine Tablets, USP subject to the recall can be identified by the NDC number on the product label. The following NDCs of Ranitidine Tablets, USP, 150 mg and 300 mg, are included in this recall:

The affected Ranitidine Tablets were distributed directly to Wholesalers, Distributors, Retailers and Repackagers nationwide.

The 150mg products product are packaged in bottle packs of 60’s, 100’s and 500’s, whereas, the 300mg products are packaged in bottle packs of 30’s, 100’s and 250’s. Photos are attached below.

Glenmark is notifying its direct customers by mailing (UPS Overnight) a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lot immediately.

Customers who purchased the impacted product directly from Glenmark and consumers can call Qualanex at 1-888-504-2012 Monday – Friday, 9:00 am – 5:00 pm, EST to arrange for product return.

Consumers who have Ranitidine Tablets, USP subject to this recall should immediately discontinue use and consult with their physician or healthcare provider about treatment options.

Consumers who would like to report any adverse reactions or quality problems experienced as a result of their use of this product, or have questions regarding the use of Ranitidine Tablets, USP can contact Glenmark Drug Safety by phone at Glenmark customer service center at 1-888-721- 7115, Monday thru Friday, 9:00 am – 6:00 pm, US EST, or e-mail at GlobalCustomerService@glenmarkpharma.com. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Source: FDA

Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

November 19, 2019 -- Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution, USP 150 mg/10 mL, is being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. This recall is being initiated in response to the recall by the manufacturer (Amneal Pharmaceuticals. LLC), which included lots that were repackaged by Precision Dose Inc.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Precision Dose Inc. has not received any reports of adverse events related to this recall to date.

Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription Ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

Ranitidine Oral Solution, USP 150 mg/10 mL is packaged in unit dose cups (NDC 68094-204-59) and sold in 30-pack cartons (68094-204-62) or 100-pack cartons (68094-204-61). The affected Ranitidine Oral Solution, USP 150 mg/10 mL lots are:

The lot number and expiration date are printed on each unit dose cup and carton label. Ranitidine Oral Solution, USP 150 mg/10 mL was distributed Nationwide to Wholesalers, Distributors and Hospitals.

Precision Dose Inc. is notifying its distributors and direct customers by certified mail and is arranging for return of all recalled products. Customers, who purchased the impacted product directly from Precision Dose Inc., can call us at 815-624-8523, Monday – Friday, 8:00 am – 4:30 pm, CST to arrange for product return. Consumers, distributors and retailers that have Ranitidine Oral Solution, USP 150 mg/10 mL, which is being recalled, should stop using and call Precision Dose Inc. at 815-624-8523 to obtain a return packet.

Consumers with questions regarding this recall can contact Precision Dose Inc. by phone (815-624-8523), Monday through Friday 8 am to 4:30 pm CST or e-mail us at: druginfo@precisiondose.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

November 15, 2019 -- Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules to the consumer level because of potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA.

GSMS, Inc. received a recall notification from the manufacturer, Novitium, on October 25th, 2019 and initiated a voluntary recall on November 6th, 2019 to the consumer level for 7 lots of Ranitidine HCl 150mg and 12 lots of Ranitidine HCl 300mg Capsules.
(Novitium’s press release: http://novitiumpharma.com/products/ranitidine-recall-press-release-final/)

To date, GSMS, Inc. has not received any reports of adverse events related to the use of the products as part of this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine Hydrochloride Capsules are indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable.

The Ranitidine Hydrochloride Capsules being recalled are supplied as follows:

• Ranitidine Hydrochloride 150mg Capsules: Caramel colored capsules, imprinted 001 on cap and novitium 150 mg on body in white ink, filled with white to pale yellow powder.
• Ranitidine Hydrochloride 300mg Capsules: Caramel colored capsules, imprinted 002 on cap and novitium 300 mg on body in white ink, filled with white to pale yellow powder.

GSMS, Inc. has promptly notified its consignees via email and certified mail. Consignees, i.e., wholesale distributors and TMOPs, are instructed to immediately stop distribution, quarantine all remaining products in their control, and return the recalled product to GSMS, Inc. The consignees are also instructed to provide their customers, i.e., pharmacies and consumers, a copy of GSMS, Inc.’s recall notification, recall response form, and letter to consumers, patients, and caregivers.

The lots under GSMS, Inc.’s voluntary recall have been primarily sold to AmerisourceBergen, McKesson, and Tricare Mail Order Pharmacies (TMOP) as listed below:

Consumers taking Ranitidine HCl capsules are advised to consult with their physician, pharmacist, or healthcare provider about an alternative treatment prior to discontinuing the use of the medication. Once an alternative treatment has been prescribed, the patients are instructed to contact Novitium‘s recall processor to obtain instructions and kit for returning the remaining product in their possession.

Manufacturer: Novitium Pharma
Recall Processor: Stericycle Return Management Services
Phone: (866) 382-8606
Email: Novitiumpharma6639@stericycle.com

Consumers with questions regarding this recall can contact GSMS, Inc, by:
Phone: (800) 284-8633, ext. 215 (Monday through Friday between 7:30 AM to 4:00 PM, Pacific)
Fax: (805) 437-7588
Email: recalls@gsms.us

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

November 12, 2019 -- Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.

Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

Amneal Pharmaceuticals, LLC. has not received any reports of adverse events that have been confirmed to be directly related to this recall. Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP), manufactured by Amneal, are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

The Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) subject to the recall can be identified by NDC numbers stated on the product label:

The affected Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) were distributed directly to Wholesalers, Distributors, Retailers and Repackagers.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal can call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST to arrange for product return.

Consumers who have Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) which are being recalled should stop using the product and can call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

The following lot numbers of Ranitidine Tablets, USP, 150 mg & 300 mg and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL are included in this recall.

Source: FDA

American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

November 8, 2019 -- American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodimethylamine (NDMA). This recall is being initiated in response to the recall by the manufacturer (Lannett Company, Inc.), which included affected lots that were repackaged by American Health Packaging.

NDMA is classified as a probable human carcinogen, a substance that can cause cancer, based on laboratory testing. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy and vegetables. No reports of injury or adverse events to date.

Ranitidine is used as a short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis.

Product was distributed Nationwide to Wholesalers for use in hospital settings.

American Health Packaging has notified its distributors by recall letter, sent November 1st, 2019, to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. American Health Packaging is arranging for return of all recalled products to lnmar Pharmaceuticals Services. Instructions for returning recalled products are given in the recall letter. Pharmacies that have received the affected lot should contact (877) 475-5864 to receive a return packet. Hours of operation are 9:00am - 5:00pm, EST Monday thru Friday.

Any general questions regarding the return of this product please contact Inmar Pharmaceuticals Services at 800-967-5952 (option 1). Hours of operation are 9:00am - 5:00pm, EST Monday thru Friday.

Consumers with questions regarding this recall can contact Inmar Pharmaceuticals Services by 800-967-5952 (option 1). Hours of operation are 9:00am - 5:00pm, EST Monday thru Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity

November 6, 2019 -- Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in the finished product. The impurity detected is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H2 receptors found in gastric parietal cells. This results in decreased gastric acid secretion and gastric volume, and reduced hydrogen ion concentration. Uses are:

• Relieves heartburn associated with acid indigestion and sour stomach.
• Prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.

Patients who prescribed or are taking Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL should continue taking their medication. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
The products subject to recall are listed below and are packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL were distributed nationwide to Aurobindo Pharma USA, Inc. and AuroHealth wholesale and distributor customers 28 September 2018 through 19 September 2019. Qualanex, on behalf of Aurobindo Pharma USA, Inc. will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:

• 1-866-850-2876 Option 2
• pvg@aurobindousa.com

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact Qualanex at 1-888-504-2014 or email recall@qualanex.com (live calls received 7:00 am to 4:00 pm M-F CST).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

October 25, 2019 -- Novitium Pharma LLC (Novitium) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. To date, Novitium has not received any reports of adverse events related to use of the product as part of this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine Hydrochloride Capsules are indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable. The affected Ranitidine Hydrochloride Capsule can be identified by NDC numbers stated on the product label. 

Source: FDA

Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

October 25, 2019 -- Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL to the consumer level due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the FDA for Ranitidine Hydrochloride Syrup (Ranitidine Oral Solution, USP). Lannett was notified by FDA of the potential presence of NDMA on September 17, 2019 and immediately commenced testing of the Active Pharmaceutical Ingredient (API) and drug product. The analysis confirmed the presence of NDMA.

Risk Statement: NDMA is classified as a probable human carcinogen, a substance that can cause cancer, based on laboratory testing. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy and vegetables.

The product is used as a short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis and is packaged in bottles of 16 fluid ounces (one pint) (NDC 54838-550-80). The affected Ranitidine Syrup lots include the following:

The product can be identified by NDC number and batch numbers provided above. Ranitidine Syrup was distributed nationwide to wholesalers/distributors.

Lannett is notifying its distributors and customers via email and via the Lannett website, and is arranging for return of all recalled products. Wholesalers and distributors (direct customers of Lannett) that have Ranitidine which is being recalled should contact Lannett customer service for instructions with regard to returning any remaining stock to Lannett.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.

October 23, 2019 -- As a precautionary measure, Sanofi on Friday, October 18, intiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States. This includes Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®. Zantac tablets are an oral, over-the-counter product to prevent and relieve heartburn associated with acid ingestion and sour stomach.

On September 13, 2019, the U.S Food and Drug Administration issued a public statement alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing.

Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. products, Sanofi has made the decision to conduct the voluntary recall as the investigation continues.

Active ingredients used in Sanofi’s ranitidine products outside of the U.S. and Canada are sourced from different suppliers. Sanofi has also issued a voluntary recall in Canada. The company is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Sanofi will be notifying its distributors and customers via email and via the Sanofi web site, and will arrange for return of all recalled products. Wholesalers (direct customers) will be asked to immediately stop distribution and return any stock to Sanofi, and contact the retail outlets in their group to do the same. Retailers will be asked to immediately stop dispensing Zantac tablets and return remaining stock to Sanofi by contacting INMAR at 877-275-0993 (option 1) or via fax at 336-499-8145 or email at zantacrecall@inmar.com. Consumers are asked to speak to their physician or pharmacist about alternate heartburn relief options.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration

Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product

October 23, 2019 -- As a precautionary measure, Perrigo Company plc announced today that it has initiated a voluntary, worldwide product recall to the retail customer level of ranitidine (all pack sizes). The recall is being taken due to possible presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine is an over-the-counter (OTC) and prescription product indicated for the relief of heartburn associated with acid indigestion and sour stomach and prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.

After regulatory bodies announced that ranitidine may potentially contain NDMA, Perrigo promptly began testing of its externally sourced ranitidine API (active pharmaceutical ingredient) and ranitidine-based products. On October 8, 2019, Perrigo halted shipments of the product based upon preliminary results. Based on the totality of data gathered to date, Perrigo has made the decision to conduct this voluntary recall.

Perrigo has the highest commitment to consumer safety and will continue to communicate ongoing testing results with health authorities. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Perrigo is notifying our retail customers by phone, email or other communication with recall notification communications to arrange for the return of all recalled product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Perrigo

Perrigo Company plc is dedicated to making lives better by bringing high quality and affordable selfcare products that consumers trust everywhere they are sold. The Company is a leading provider of over-the-counter health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at http://www.perrigo.com.

Perrigo Contact
(888) 817-2180

Perrigo Investor Contact
Bradley Joseph, Vice President, Global Investor Relations & Corporate Communications, (269) 686-3373, E-mail: bradley.joseph@perrigo.com

Lyndsey Chmiel, Senior Manager, Global Investor Relations & Corporate Communications, (269) 673-9324, E-mail: lyndsey.chmiel@perrigo.com

Source: FDA

Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market

October 23, 2019 -- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries, together referred to as “Dr. Reddy’s”) confirms it had initiated a voluntary nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at the consumer level for prescription products) of all of its ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA. This recall follows the USFDA’s caution note alerting patients and health care professionals that NDMA was found in certain samples of ranitidine. To date, Dr. Reddy’s has not received any reports of adverse events related to the recall of Dr. Reddy’s Ranitidine products. The recall includes all quantities in the US that are within expiry.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine is available as an over-the-counter (OTC) and prescription drug. Over-the-counter (OTC) ranitidine tablets are used to relieve heartburn associated with acid indigestion and sour stomach. OTC Ranitidine Tablets are also used to prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages. Prescription ranitidine capsules are prescribed for the short-term treatment of active duodenal ulcer; maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers; treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome and systemic mastocytosis); short-term treatment of active, benign gastric ulcer; maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers; treatment of GERD (Gastroesophageal reflux disease); treatment of endoscopically diagnosed erosive esophagitis; and for maintenance of healing of erosive esophagitis.

Dr. Reddy’s Ranitidine products can be identified by NDC numbers on the product label. All Ranitidine products with expiration dated September 2019 to June 2021 are being recalled:

If consumers have questions regarding this recall or to report an adverse event, please contact the Company’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 8 p.m. ET, Monday through Friday. Patients should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality concerns experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail 0r call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Apotex Corp. Issues Voluntary Recall of Ranitidine Tablets 75mg and 150mg Due to Detection of an Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in the Product

September 25, 2019 -- Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. To date, Apotex has not received any reports of adverse events related to use of the product.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine Hydrochloride Tablet is an over the counter (OTC) oral product indicated for the relief of heartburn associated with acid indigestion and sour stomach and prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages. The affected Ranitidine Hydrochloride Tablets can be identified by NDC numbers stated on the product label.

Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in the Product

September 23, 2019 -- Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz has not received any reports of adverse events related to use of the product as part of this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine Hydrochloride Capsules is an oral product, indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable. The affected Ranitidine Hydrochloride Capsule can be identified by NDC numbers stated on the product label.

The affected Sandoz Ranitidine includes 30 count, 60 count and 500 count bottles in the following lots:

The product can be identified by the NDC number and lot number provided above. Sandoz Ranitidine Hydrochloride Capsules were distributed nationwide to wholesalers.

Sandoz will be notifying its distributors and customers via overnight mail and via the Sandoz web site, and will arrange for return of all recalled products. Wholesalers (direct customers) will be asked to immediately stop distribution and return any stock to Sandoz, and contact the retail pharmacies in their group to do the same. Pharmacies will be asked to immediately stop dispensing Sandoz Ranitidine Hydrochloride Capsules and return remaining stock to Sandoz by contacting Stericycle to request a recall packet. Consumers are asked to continue taking their medication and speak to their physician or pharmacist on alternate healthcare treatment options.

Consumers with questions regarding this recall can contact Sandoz at 1-800-525-8747 option # between 8:30am – 5:00pm Monday – Friday EST or www.us.sandoz.com for more information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. This information and package photos are available at https://www.us.sandoz.com/patients-customers/product-safety-notices

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration

Source: FDA

Safety Information: Ranitidine Generics - NDMA Found in Samples of Some Ranitidine Medicines

September 13, 2019

ISSUE: FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

BACKGROUND: Ranitidine is an over-the-counter (OTC) and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. Over-the-counter Ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription Ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.

RECOMMENDATION: The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Source: FDA