Ocular lubricant FDA Alerts

Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Eye Ointment Products Due to Potential Lack of Sterility

22 February, 2024 – Thane, Maharashtra, India, Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA).

Risk Statement: For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to 16th February 2024 related to this recall.

These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc.

Brassica Pharma Pvt. Ltd. Is notifying its distributors AACE Pharmaceuticals Inc and its retailers Walmart and CVS. These distributors shall be further notifying the wholesalers and retailers via mail of this voluntary recall and arranging for return of all impacted products listed above. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled Eye Ointment and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Brassica Pharma Pvt. Ltd. at +1 833-225-9564 or info@brassicapharma.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

Kilitch Healthcare India Limited Issues Amendments in Last Voluntary Nationwide Recall Press Release

January 05, 2024– Mumbai, Maharashtra, Kilitch Healthcare India Limited is issuing an amendment in the last Nationwide press release dated November 13, 2023 issued for nationwide recall of various eye drops. There are corrections in product NDC No for the below mentioned products.

These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC.

Kilitch Healthcare India Limited, is notifying its distributor Velocity Pharma LLC and its distributor Velocity Pharma LLC shall be further notifying the wholesalers and retailers via mail of this voluntary recall and is arranging for return of all impacted products listed above. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled eye drops and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact regulatory@velocitypharma.com or regulatory@kilitchhealthcare.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: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

Original Press Release

Source: FDA

Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons

November 13, 2023– Mumbai, Maharashtra, Kilitch Healthcare India Limited is voluntarily recalling the eye drops products listed in the table below to the consumer level with all lots within expiry with expiration dates ranging from November, 2023 to September, 2025 for all the below mentioned products. These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions.

Risk Statement: For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.

These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC.

Kilitch Healthcare India Limited, is notifying its distributor Velocity Pharma LLC and its distributor Velocity Pharma LLC shall be further notifying the wholesalers and retailers via mail of this voluntary recall and is arranging for return of all impacted products listed above. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled eye drops and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact regulatory@velocitypharma.com or regulatory@kilitchhealthcare.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: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections

October 31, 2023 – La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to the consumer level. The Harvard Drug Group, LLC received information from FDA indicating investigator found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.

Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss of blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. The Harvard Drug Group, LLC has received three (3) reports of adverse events related to these products including reports of vision blurriness, vision loss, and burning eyes. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.

Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) are available as over the counter (OTC) products used for temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun and the product used as a protectant against further irritation or to relieve dryness of the eye.

Both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be identified on the outer carton labeling as follows:

Images of the outer carton labelling of both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be found below.

Products were distributed Nationwide starting June 1, 2021.

The Harvard Drug Group, LLC is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, Distributors and Retailers that have the affected product which is being recalled should cease distribution of the products. Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1- 866-891-1981 (8:00am-5:00pm EST Monday through Friday) or by email address harvarddrug8430@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.

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: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

Cardinal Health, Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections

October 31, 2023 – Dublin, OH, Cardinal Health, Inc. is initiating a voluntarily recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.

Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. To date, Cardinal Health, Inc., and its subsidiaries have received reports of three (3) adverse events related to these listed products. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.

These products are available as over the counter (OTC) products used for temporary relief of burning and irritation due to dryness of the eye, for use as a protectant against further irritation or to relieve dryness of the eye, and/or to relieve redness of the eye due to minor eye irritations.

These products can be identified on the outer carton labeling as follows:

Images of the outer carton labeling of these listed products can be found below.

Products were distributed Nationwide to Wholesalers and Retailers starting December 12, 2021.

Cardinal Health, Inc. is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, Distributors and Retailers that have the affected product which is being recalled should cease distribution of the products. Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1-855-215-4940 (8:00am-5:00pm EST Monday through Friday) or by email at Cardinalhealth7720@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.

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: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

FDA Warns Consumers Not To Purchase or Use Certain Eye Drops From Several Major Brands Due to Risk of Eye Infection

Source: FDA

Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility

March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility.

Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness.

To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product.

Product was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. Amazon Marketplace, Etc.).

The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles. The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids. The product can be identified by the labels below.

Pharmedica USA LLC is advising customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification.

Consumers with questions regarding this recall can contact Pharmedica USA LLC by phone number at +1 (623) 698 - 1752 or e-mail address at osm@pharmedicausa.com Monday to Friday between the hours of 8:00 AM MST (AZ) and 5:00 PM MST (AZ).. 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

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination

February 23, 2023 -- Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised.

Risk Statement: Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product.

Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.) is used as an eye lubricant and to relieve dryness of the eyes. The affected product is packaged in a white aluminum tube within a paper carton. The product can be identified by the photos provided below. The product was distributed nationwide in the United States, and by Delsam through internet retail sites. Delsam Pharma’s NDC for this product is 72570-122-35, and its UPC code is 3 72570 012235 3.

Global Pharma Healthcare is notifying the brand owner and importer of this product, Delsam Pharma, about this recall, and is requesting that wholesalers, retailers, and customers who have the recalled product should stop any use and discard the product safely and appropriately.

Consumers with questions regarding this recall can contact the distributor Delsam Pharma, LLC by phone at 1-866-826-1306 or by e-mail at delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products.

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: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

FDA Warns Consumers Not to Purchase or Use EzriCare Artificial Tears Due to Potential Contamination

These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile.

Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. FDA recommended this recall due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.

FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and state and local health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. As of January 31, 2023, CDC identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. CDC issued an alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA.

FDA also placed Global Pharma Healthcare Private Limited on import alert for providing an inadequate response to a records request and for not complying with CGMP requirements. The import alert prevents these products from entering the United States. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Consumers may also report adverse reactions by contacting FDA’s Consumer Complaint Coordinators.

Source: FDA

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Over-The-Counter Ophthalmic Products Sold By Accutome, Focus Laboratories, Grandall Distributing Co. Inc. And Prestige

July 16, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold by Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige Brands Inc., during the time period as indicated in the tables below. As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.

This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. No other lots are being recalled. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets.

Altaire further advises as follows:

TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.
TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS.

ACCUTOME

Product Description:

Accutome Accu-WASH

NDC# 63448-411-04 Product Size: 4 FL. OZ.

FOCUS LABORATORIES

Product Description:

FreshKote Lubricant Eye Drops

NDC# 15821-101-15 Product Size: 15 mL

GRANDALL DISTRIBUTING CO., INC.

Product Description:

Grandall Colirio Ojo De Aguila Eye Drops

Product Size: 15 mL

Product Description:

Grandall Colirio Oftal-Mycin Redness Relief Eye Drops

Product Size: 15mL

Product Description:

Grandall Oftal-Mycin Ophthalmic Ointment

Product Size: 3.5 g

PRESTIGE

Product Description:

Clear Eyes Redness Relief

UPC#: 6-78112-25415-6 Product Size: 15 mL

Product Description:

Clear Eyes Redness Relief

UPC#: 6-78112-25419-4 Product Size: 30 mL

Product Description:

Clear Eyes Redness Relief (Handy Pocket Pal)

UPC#: 6-78112-15418-7 Product Size: 0.2 FL. Oz.

Product Description:

Clear Eyes Redness Relief (Little Drug)

UPC#: 7-92554-70103-7 Product Size: 0.2 FL. Oz.

Product Description:

Clear Eyes Redness Relief (Select Corp)

UPC#: 6-55708-01039-6 Product Size: 0.2 FL. Oz.

The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. Altaire ships the products labeled for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige only to Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige, respectively. The products are distributed at the retail level by the labelers identified herein. Altaire has also requested that the labelers each perform a subrecall.

Altaire has notified Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige by e-mail on July 16, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots.

Any questions regarding this VOLUNTARY RECALL to the RETAIL LEVEL can be directed to Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET.

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.

• 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.

Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.

Source: FDA

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Manufactured and Distributed as Altaire Labeled Products

July 15, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the over the counter (OTC) and prescription (Rx) drug products and lots, within expiry, it has manufactured and distributed under the Altaire label and trade dress during the time period as indicated below. As a precautionary measure, Altaire is voluntarily initiating this recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.

This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. No other lots are being recalled. A Retail Level recall is limited to product lots currently in inventory on hand at any distributor to which Altaire Pharmaceuticals, Inc. has sold these products.

Altaire further advises as follows:

TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.

TO DATE, ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATION RESULTS, INCLUDING IN-HOUSE AND THIRD-PARTY STERILITY TESTING, FOR THESE PRODUCTS.

Product Description:

ActivEyes Nighttime Lub Eye Ointment Preservative Free

NDC#: 59390-190-50 Product Size: 3.5 g

Product Description:

Altaire Altacaine Solution

NDC#: 59390-181-13 Product Size: 15 mL

Product Description:

ActivEyes Altachlore Ointment

NDC#: 59390-184-50 Product Size: 3.5 gram

Product Description:

ActivEyes Altachlore Solution

NDC#: 59390-183-13 Product Size: 15 mL

Product Description:

ActivEyes Altalube Ointment

NDC#: 59390-198-50 Product Size: 3.5 gram

Product Description:

Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%

NDC#: 59390-217-02 Product Size: 2.5 mL

Product Description:

Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%

NDC#: 59390-217-05 Product Size: 5 mL

Product Description:

Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%

NDC#: 59390-217-10 Product Size: 10 mL

Product Description:

Altaire Diclofenac Sodium Solution 1%

NDC#: 59390-149-02 Product Size: 2.5 mL

Product Description:

Altaire Diclofenac Sodium Solution 1%

NDC#: 59390-149-05 Product Size: 5 mL

Product Description:

Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution

NDC#: 59390-205-05 Product Size: 5 mL

Product Description:

Altaire Eye Wash

NDC#: 59390-175-13 Product Size: 15 mL

Product Description:

Altaire Eye Wash

NDC#: 59390-175-18 Product Size: 1 Fl. Oz.

Product Description:

Altaire Eye Wash

NDC#: 59390-175-35 Product Size: 4 Fl. Oz.

Product Description:

Altaire Goniotaire

NDC#: 59390-182-13 Product Size: 15 mL

Product Description:

Altaire Homatropaire

NDC#: 59390-192-05 Product Size: 5 mL

Product Description:

NanoTears HA PF Multi Dose Lubricant Gel Drops

NDC#: 59390-208-10 Product Size: 10 mL

Product Description:

Nano Tears MO Clear Emollient Mineral Oil Lipids

NDC#: 59390- 145-10 Product Size: 10 mL

Product Description:

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops

NDC#: 59390-144-10 Product Size: 10 mL

Product Description:

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack

NDC#: 59390-144-51 Product Size: 2 x 10 mL

Product Description:

Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose

NDC#: 59390-141-52 Product Size: 7.5 mL

Product Description:

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free

NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct.

Product Description:

Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free

NDC#: 59390-141-56 Product Size: 0.6 mL x 32 ct.

Product Description:

Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack

NDC#: 59390-142-49 Product Size: 2 x 15 mL

Product Description:

Nano Tears TF Clear Emollient Lubricant Gel Drops

NDC#: 59390-142-13 Product Size: 15 mL

Product Description:

Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack

NDC#: 59390-143-51 Product Size: 2 x 10 mL

Product Description:

Nano Tears XP Clear Emollient Lubricant Gel Drops

NDC#: 59390-143-10 Product Size: 10 mL

Product Description:

Altaire Ofloxacin 0.3% Ophthalmic Solution USP

NDC#: 59390-140-05 Product Size: 5 mL

Product Description:

ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF

NDC#: 59390-148-52 Product Size: 7.5 mL

Product Description:

ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF

NDC#: 59390-146-52 Product Size: 7.5 mL

Product Description:

ActivEyes Lubricant Eye Ointment Preservative Free

NDC#: 59390-189-50 Product Size: 3.5 gram

The foregoing products are manufactured and labeled by Altaire Pharmaceuticals, Inc. Altaire has notified all distributors by e-mail on July 15, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Any questions regarding this VOLUNTARY RECALL to the RETAIL LEVEL can be directed to Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET. 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. Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.

Source: FDA

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products Sold At CVS

July 10, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at CVS Health the during the time period as indicated in the tables below. As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.

This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. No other lots are being recalled. A Retail Level recall is limited to product lots currently in inventory at the chain store.

Altaire further advises as follows:

TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.

TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS.

Product Description:

CVS Health Natural Tears Lubricant Eye Drops Preservative Free

Item#: 538397 Product Size: 0.6 mL x 32 ct

Product Description:

CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye

Item#: 317916 Product Size: 15 mL

Product Description:

CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye

Item#: 247887 Product Size: 30 mL

Product Description:

CVS Health Dry Eye Relief Eye Drops

Item#: 317914 Product Size: 15 mL

Product Description:

CVS Health Dry Eye Relief Eye Drops

Item#: 457802 Product Size: 30 mL

Product Description:

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution

Item#: 495334 Product Size: 0.6 mL x 60 ct

Product Description:

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution

Item#: 994883 Product Size: 0. 6 mL x 30 ct

Product Description:

CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief

Item#: 634634 Product Size: 0.6 mL x 30

Product Description:

CVS Health Lubricating Gel Drops for Anytime Use

Item#: 563420 Product Size: 10 mL

Product Description:

CVS Health Overnight Lubricating Eye Ointment

Item#: 881532 Product Size: 3.5 gram

Product Description:

CVS Health Lubricant Eye Ointment

Item#: 247881 Product Size: 3.5 gram

Product Description:

CVS Health Extra Strength Lubricant Gel Drops

Item#: 799143 Product Size: 15 mL

Product Description:

CVS Health Extra Strength Lubricant Gel Drops Twin Pack

Item#: 258587 Product Size: 2 x 15 mL

Product Description:

CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy

Item#: 895160 Product Size: 15 mL

Product Description:

CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack

Item#: 994881 Product Size: 2 x 10 mL

Product Description:

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution

Item#: 495301 Product Size: 0.6 mL x 30ct

Product Description:

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution

Item#: 457791 Product Size: 0.6 mL x 70ct

Product Description:

CVS Health Preservative Free Lubricant Eye Drops Advanced Relief

Item#: 563442 Product Size: 0.6 mL x 30

Product Description:

CVS Health Lubricant Eye Drops Advanced Relief

Item#: 563419 Product Size: 10 mL

Product Description:

CVS Health Fast Acting Lubricant Eye Drops Preservative Free

Item#: 994882 Product Size: 0.6 mL x 24 ct

Product Description:

CVS Health Preservative Free Lubricant Eye Drops Fast Acting

Item#: 258625 Product Size: 0.6 mL x 60 ct

Product Description:

CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief

Item#: 799145 Product Size: 30 mL

Product Description:

CVS Health Multi-Action Relief Drops

Item#: 694954 Product Size: 15 mL

Product Description:

CVS Health Lubricant Eye Drops Lasting Dry Eye Relief

Item#:968210 Product Size: 10 mL

Product Description:

CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack

Item#: 495323 Product Size: 2 x 10 mL

Product Description:

CVS Health Maximum Redness Relief Eye Drops

Item#: 994880 Product Size: 15 mL

Product Description:

CVS Health Redness Relief

Item#: 317912 Product Size: 15 mL

Product Description:

CVS Health Redness Relief

Item#: 457799 Product Size: 30 mL

Product Description:

CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief

Item#: 563431 Product Size: 15 mL

Product Description:

CVS Health Lubricant Eye Ointment Sensitive Formula

Item#: 247885 Product Size: 3.5 gram

The products are manufactured and labeled exclusively for CVS Health. Altaire ships the products labeled for CVS only to CVS. The products are distributed at the retail level by CVS. Altaire has notified CVS by e-mail on July 10, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Any questions regarding this VOLUNTARY RECALL to the RETAIL LEVEL can be directed to Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET. 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.

Source: FDA

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Wal Mart

July 5, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Wal-Mart during the time period as indicated in the tables below. As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed above. No other lots are being recalled.

Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including Sterility testing, for the products.

Product Description:

Equate Restore Tears Lubricant Eye Drops Twin Pack

W-M item #: 552374320 NDC #: 49035-189-49 Package Size: 2 x 15 mL

Product Description:

Equate Eye Allergy Relief Drops

W-M item #: 567371432 NDC #: 49035-887-13 Package Size: 15 mL

Product Description:

Equate Sterile Lubricant Stye Ointment

W-M item #: 563031651 NDC #: 49035-875-50 Package Size: 3.5 gram

Product Description:

Equate Comfort Gel Lubricant Eye Gel Twin Pack

W-M item #: 552374319 NDC #: 49035-197-49 Package Size: 2 x 15 mL

Product Description:

Equate Restore PM Nighttime Lubricant Eye Ointment

W-M item #: 551282425 NDC #: 49035-191-50 Package Size: 3.5 gram

Product Description:

Equate Night & Day Restore Tears Lubricant Eye Pack

W-M item #: 567368000 NDC #: 49035-883-59 Package Size: 3.5g and 15mL

Product Description:

Equate Support Advanced Twin Pack

W-M item #: 567371433 NDC #: 49035-885-49 Package Size: 2 x 15 mL

Product Description:

Equate Support Advanced Lubricating Eye Drops Dose Preservative Free

W-M item #: 563031654 NDC # 49035-882-54: Package Size: 25 count (0.6 mL fill):

Product Description:

Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free

W-M item #: 567367998 NDC #: 49035-882-52 Package Size: 7.5 mL

Product Description:

Equate Support Moisture Lubricant Eye Drops

W-M item #: 553503238 NDC #: 49035-145-10 Package Size:10 mL

Product Description:

Support Harmony Lubricant Eye Drops

W-M item #: 553503238 NDC #: 49035-145-10 Package Size: 10 mL
(Note: Support Harmony packaging was discontinued in January 2018.)

The products are manufactured and labeled exclusively for Wal-Mart. Altaire ships the products labeled for Wal-Mart only to Wal-Mart. The products are distributed at the retail level by Wal-Mart. Altaire has also requested that Wal-Mart notify its customers.

Altaire has notified Wal-Mart by e-mail on July 3, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots.

Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET. Customers 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 associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.

Source: FDA

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Walgreens

July 3, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Walgreens during the time period as indicated in the tables below. As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed above. No other lots are being recalled.

Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including Sterility testing, for the products.

Product Description: Lubricant Eye Drops Moisturizing
Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL

Product Description: Lubricant Eye Drops Moisturizing Twin Pack
Walgreens item #: 801477 NDC #: 0363-0185-49 Package Size: 2 x 15 mL

Product Description: Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment
Walgreens item #: 801482 NDC #: 0363-7500-50 Package Size: 3.5 gram

Product Description: Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops
Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL

Product Description: Lubricant Eye Ointment PF Soothing
Walgreens item #: 801486 NDC #: 0363-0191-50 Package Size: 3.5 gram

The products are manufactured and labeled exclusively for Walgreens. Altaire ships the products labeled for Walgreens only to Walgreens. The products are distributed at the retail level by Walgreens. Altaire has also requested that Walgreens notify its customers.
Altaire has notified Walgreens by e-mail on July 3, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots.

Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday through Friday from 8:30 a.m. to 5:00 p.m. ET. Customers 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.

Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.

Source: FDA

Altaire Pharmaceuticals Carboxymethylcellulose Sodium 0.5 Percent Ophthalmic Solution Sold Under Wal-Mart, CVS, and Target Brands: Recall - Preservative May Not Be Effective Through Expiry

ISSUE:  Altaire Pharmaceuticals, Inc., announced that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. Due to complaints of mold found in the 30 mL bottles after use, concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall.

A product whose preservative may not be effective could lead to the use of a contaminated product which creates a potential risk for eye infection.

BACKGROUND: Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box.

The product is labeled as follows (refer the Firm Press Release for a detailed product list containing affected lot numbers):

• equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) - Distributed by Wal-Mart Stores, Inc.
• Lubricant EYE DROPS FOR MILD TO MODERATE DRY EYE, STERILE, 1 FL OZ (30 mL), for Mild to Moderate Dry Eye - Distributed by CVS Pharmacy, Inc.
• lubricant eye drops for mild to moderate dry eye, STERILE, 1 FL OZ (30 mL) - Dist. by Target Corp.

RECOMMENDATION: Consumers who have the product with any of the lot numbers listed in the Firm Press Release should stop use of the product immediately and return it to the place of purchase.

Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday – Friday from 9 am – 5 pm ET. 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.

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: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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

[09/06/2013 - Firm Press Release - FDA]