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Dexpak Taperpak FDA Alerts

The FDA Alerts below may be specifically about Dexpak Taperpak or relate to a group or class of drugs which include Dexpak Taperpak.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Dexpak Taperpak

FDA Warns Consumers Not to Purchase or Use Artri and Ortiga Products, Which May Contain Hidden Drug Ingredients

April 20, 2021 --FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. FDA urges consumers taking these products to immediately talk to their health care professional (e.g., doctor) to safely discontinue use of the product because suddenly stopping these drugs may be dangerous.

These products are promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions and are sold on various websites and in some retail stores.

FDA laboratory analyses revealed certain Artri and Ortiga products contain the undeclared drug ingredients:

  • Dexamethasone (a corticosteroid) that can cause serious adverse events, including infections, increased blood glucose (sugar) levels, changes in blood pressure, damage to bones, psychiatric problems, and adrenal dysfunction;
  • Diclofenac sodium (an anti-inflammatory drug) that can lead to adverse cardiovascular events, such as heart attack and stroke, or serious gastrointestinal damage, including bleeding, ulceration, and fatal tears of the stomach and intestines, or liver toxicity including liver failure that can cause the need for a liver transplant or death
  • Methocarbamol (a muscle relaxant) that can cause sedation, dizziness, and low blood pressure.

These drug ingredients, which are not listed on the product label, can also interact with other drugs a consumer is taking.

FDA has received adverse event reports, including of liver toxicity and death, associated with the use of Artri King products, since the agency issued its first warning about an Artri Ajo King product on January 5, 2022.

Suddenly stopping corticosteroids after long-term use or high doses can result in a serious withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood glucose levels, fever, dizziness, muscle and joint pain, and shortness of breath. These risks depend on several factors that a health care professional must assess. Medical intervention may be necessary.

Health care professionals should evaluate patients who have used Artri and Ortiga products for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and treat accordingly.

FDA has identified the following Artri and Ortiga products containing hidden drug ingredients:

FDA analyses reflect only the undeclared ingredients discovered in one product from a specific lot, but ingredients may vary from product to product or from lot to lot. Products marketed as dietary supplements that are found to have hidden drug ingredients generally fail to comply with most current good manufacturing practices designed to ensure product quality and safety. Therefore, consumers should expect the manufacturing processes for Artri and Ortiga products are unreliable in providing consistent amounts of active ingredients or to prevent the introduction of unknown chemicals or other impurities.

FDA is investigating the distribution of these products in the United States and has advised certain companies not to sell or distribute these products. The agency may take additional enforcement steps that may include warning letters, seizure, injunction, or criminal charges.

Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Source: FDA


Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance

December 4, 2021 – Colchester, VT, Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC to the consumer level. All products are being recalled due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products.

Risk Statement: Administration of a drug product intended to be sterile, that is not sterile, could result in site specific infections as well as serious systemic infections which may be life- threatening. To date, Edge Pharma, LLC has not received and is not aware of any adverse events related to this recall.

The products are used for a variety of indications and are packaged in Containers, IV bags, Syringes, Drop containers, Vials, Bottles, and Jars. The affected lots and expiration dates are included in the link listed below. The names and concentration of the drugs are listed in the table following this release.

LINK TO LOT NUMBERS, DISTRIBUTION DATES & DRUG INFORMATION WILL BE ACTIVE ON 12-08-21.

https://edgepharma.com/assets/recalledproducts.pdf

The recall encompasses all compounded sterile and nonsterile drug products, within expiry, that were dispensed from Edge Pharma, LLC. The products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The products can be identified by the label containing the Edge Pharma, LLC name and logo.

Edge Pharma, LLC is notifying its customers by email, Media and FDA alerts, and direct outreach. Consumers and institutions that have Edge Pharma, LLC products should stop using the products immediately and may either return or discard the recalled lots.

Consumers with questions regarding this recall can contact Edge Pharma, LLC by phone number or e-mail address on Monday-Friday from 8:00 am to 4:00 pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these 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
  • 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.

STERILE PRODUCTS NDC
ALUMINUM POTASSIUM SULFATE CONCENTRATED (PF) 300 G/300 ML 05446-0637-03
BUFFERED LIDOCAINE HCL (PF) 1% 05446-0850-10
BUFFERED LIDOCAINE HCL / EPINEPHRINE SOLUTION (PF) 1% / 1:100,000 05446-1268-01
CEFTAZIDIME (PF) 22.5 MG/ML 05446-0733-01
CEFUROXIME OPHTHALMIC SOLUTION (PF) 10 MG/ML 05446-1003-01
DEXAMETHASONE PHOSPHATE (PF) 24 MG/ML 05446-0848-01
EDETATE DISODIUM (EDTA) (PF) 1.5% 05446-1427-10
EDETATE DISODIUM (EDTA) (PF) 3% 05446-1428-10
EPINEPHRINE / LIDOCAINE HCL (PF) 0.025% / 0.75% 05446-0863-01
GEMCITABINE (PF) 20 MG/ML 05446-1566-50
GLYCERIN, STERILE (PF) 99% 05446-1486-03
LIDOCAINE HCL / BUPIVACAINE HCL / HYALURONIDASE (PF) 2% / 0.375% / 15 UNITS/ML 05446-1548-18
METHACHOLINE CHALLENGE 5 SYRINGE TEST KIT 05446-1600-05
METHACHOLINE CHLORIDE (PF) 16 MG/ML 05446-1241-01
METHACHOLINE CHLORIDE (PF) 4 MG/ML 05446-1246-01
METHACHOLINE CHLORIDE (PF) 1 MG/ML 05446-1247-01
METHACHOLINE CHLORIDE (PF) 0.25 MG/ML 05446-1248-01
METHACHOLINE CHLORIDE (PF) 0.0625 MG/ML 05446-1249-01
METHOTREXATE (PF) 125 MG/5ML 05446-1505-05
MITOMYCIN IRRIGATION (PF) 1 MG/ML 05446-1416-01
MITOMYCIN-C (PF) 0.4 MG/ML 05446-1009-01
MITOMYCIN-C (PF) 0.2 MG/ML 05446-1011-01
MOXIFLOXACIN HCL (PF) 1 MG/ML 05446-1050-01
MVASI 3.75MG/0.15ML (25 MG/ML) 05446-1661-13
NEOSTIGMINE METHYLSULFATE 1 MG/ML 05446-1549-05
NOREPINEPHRINE BITARTRATE 8 MG/250ML 05446-1179-03
PHENOL, STERILE (PF) 6% 05446-1476-05
PHENYLEPHRINE / TROPICAMIDE / KETOROLAC / CIPROFLOXACIN (PF) 10% / 1% / 0.125% / 0.3% 05446-1270-01
PHENYLEPHRINE HCL 0.1 MG/ML 05446-1544-10
PHENYLEPHRINE HCL 0.1 MG/ML 05446-1545-05
PHENYLEPHRINE HCL (PF) 800 MCG/10 ML 05446-1652-01
PHENYLEPHRINE HCL (PF) 20 MG/ 250 ML 05446-1667-01
PHENYLEPHRINE HCL / LIDOCAINE HCL (PF) 1.5% / 1% 05446-1118-01
PHENYLEPHRINE HCL / TROPICAMIDE 2.5% / 1% 05446-0815-01
PHENYLEPHRINE/ CYCLOPENTOLATE / TROPICAMIDE / KETOROLAC 10% / 0.25% / 0.25% / 0.125% 05446-0859-03
PHENYLEPHRINE/ CYCLOPENTOLATE / TROPICAMIDE / KETOROLAC (PF) 2.5% / 0.25% / 0.25% / 0.125% 05446-0993-01
POVIDONE-IODINE (PF) 5% 05446-1680-01
TRYPAN BLUE (PF) 0.03% 05446-1200-01
VANCOMYCIN HCL (PF) 10 MG/ML 05446-0736-01
VANCOMYCIN HCL (PF) 1250 MG/250ML 05446-1456-01
VANCOMYCIN HCL (PF) 1500 MG/512ML 05446-1458-01
VANCOMYCIN HCL (PF) 1750 MG/514ML 05446-1459-01
STERILE PRODUCTS NDC
PRESCRIPTION ALLERGY TREATMENT SETS DISTRIBUTED BETWEEN 12-02-20 to 12-01-21 N/A
NON-STERILE PRODUCTS NDC
BENZOCAINE / LIDOCAINE / TETRACAINE 20% / 8% / 4% 05446-1235-01
CANTHARIDIN 0.7% 05446-0572-03
CANTHARIDIN PLUS 1% / 30% 05446-0970-03
CIPROFLOXACIN / SULFACETAMIDE SODIUM / AMPHOTERICIN B 30MG / 50MG / 5MG 05446-1633-01
CIPROFLOXACIN / SULFACETAMIDE SODIUM / AMPHOTERICIN B /
HYDROCORTISONE 30MG / 50MG / 5MG / 25MG
05446-1634-01
DEXAMETHASONE IONTOPHORESIS 0.4% 05446-0622-01
DIBUTYL SQUARATE 2% 05446-1047-03
DIBUTYL SQUARATE 1% 05446-1156-03
LIDOCAINE / TETRACAINE 23% / 7% 05446-1647-01
LIDOCAINE HCL / EPINEPHRINE / TETRACAINE HCL (LET) 4%/0.05%/0.5% 05446-0607-01
LIDOCAINE HCL / OXYMETAZOLINE 4% / 0.05% 05446-1256-01
LIDOCAINE HCL / PRILOCAINE HCL / TETRACAINE HCL
(PROFOUND) DENTAL (RASPBERRY MARSHMALLOW) 10% / 10% / 4%
05446-0790-10
LIDOCAINE HCL / PRILOCAINE HCL / TETRACAINE HCL
(PROFOUND) DENTAL GEL (MINT) 10% / 10% / 4%
05446-0407-10
LIDOCAINE HCL / PRILOCAINE HCL / TETRACAINE HCL /
PHENYLEPHRINE HCL (PROFOUND-PE) DENTAL (RASPBERRY MARSHMALLOW) 10% / 10% / 4% / 2%
05446-1018-10
LIDOCAINE HCL / PRILOCAINE HCL / TETRACAINE HCL /
PHENYLEPHRINE HCL (PROFOUND-PE) DENTAL GEL (MINT) 10% / 10% / 4% / 2%
05446-0408-10
PHENOL 89% 05446-1211-03
PHENYLEPHRINE HCL / LIDOCAINE HCL 1% / 4% 05446-1045-03
PHYTONADIONE (VITAMIN K) 5 MG/ML 05446-1132-03
PROMETHAZINE HCL 25 MG / 1.2ML 05446-1341-01
TETRACAINE HCL 4% 05446-1195-03
VANCOMYCIN HCL 125 MG / 2.5ML (50 MG/ML) 05446-1348-01

Source: FDA


Mayhem: Public Notification - Undeclared Drug Ingredients

ISSUE: FDA is advising consumers not to purchase or use Mayhem, a product labeled as a dietary supplement that is promoted to increase appetite and muscle growth, because it contains an undeclared corticosteroid and antihistamine. FDA laboratory analysis found that Mayhem contains dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment.
 
Consumers are advised that corticosteroid use can impair a person’s ability to fight infections, cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland and cause withdrawal symptoms with abrupt discontinuation. Antihistamines may cause drowsiness and affect mental alertness.
 
In addition, these undeclared drug ingredients in Mayhem may cause serious side effects when combined with other medications.

BACKGROUND: Mayhem is manufactured by Chaotic-Labz and is sold in some retail stores and on various websites, including www.chaoticlabz.com

RECOMMENDATION: Consumers taking Mayhem are urged to immediately consult with their health care provider to safely discontinue use of this product. This risk of withdrawal from corticosteroids should be assessed by a health care professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression.

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

[11/13/2014 - Public Notification - FDA]
[11/14/2014 - Tainted Body Building Products - FDA]


Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems

Including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone

[Posted 04/23/2014]

ISSUE: FDA is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use. 

FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.

BACKGROUND: To raise awareness of the risks of epidural corticosteroid injections in the medical community, FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized. FDA will convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.

RECOMMENDATION: Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. See the Drug Safety Communication for a Data Summary and additional information for both patients and healthcare professionals.

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:

[04/23/2014 - Drug Safety Communication - FDA]
 


Reumofan Plus: Recall - Undeclared Drug Ingredient

Reumofan Plus USA, LLC and Reumofan USA, LLC is recalling "Reumofan Plus" Tablets, Lot# 99515, exp. 09/16, because they contain undeclared active pharmaceutical ingredients: methocarbamol, dexamethasone, and diclofenac. The recall was initiated after it was discovered that the product was distributed in packaging that did not reveal the presence of the active pharmaceutical ingredients, making it an unapproved drug. One illness has been reported to date in connection with this problem.

[UPDATED 8/28/2012]

Samantha Lynn Inc. is voluntarily recalling 500 lots of Reumofan Plus Tablets to the consumer level due to findings of undeclared drug ingredients. The FDA sample analysis has found the product to contain methocarbamol and diclofenac. The affected Reumofan Plus lots may include the following lot number(s): 99515 ex096 and expires: 2016. The product is marketed in a green bottle containing 30 lavender round tablets and is distributed nationwide via the internet.

[UPDATED 08/21/2012]

FDA is issuing an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared active ingredients found in prescription drugs that should be used only under the supervision of a health care professional.

Since June 1, 2012, when FDA first warned the public about the dangers of these supplements, the agency has received reports of fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome

Because of the possible risks, consumers should not buy or start using these products.

[Posted 06/01/2012]

ISSUE: FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful. An FDA laboratory analysis of Reumofan Plus found that it contains Diclofenac Sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines, and Methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.

FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.

BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.

RECOMMENDATION: Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately. Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.


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:

[08/21/2012 - News Release - FDA]
[08/21/2012 - Consumer Update - FDA]
[06/01/2012 - News Release - FDA]


Reumofan Plus Dietary Supplement Relabeled and Sold as “WOW”: Public Warning - Undeclared Drug Ingredients

ISSUE: The U.S. Food and Drug Administration (FDA) is warning the public that the potentially harmful dietary supplement product Reumofan Plus is being relabeled and sold under the name “WOW.”  The product is being marketed to treat arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.  FDA laboratory analysis confirmed that “WOW” contains the same prescription drug ingredients that are in Reumofan Plus, including dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug), and methocarbamol (a muscle relaxant).  These ingredients have the potential to cause serious injury.

BACKGROUND: FDA warned the public of the harm of Reumofan Plus on June 1, 2012, and again on August 21, 2012.  Since June, FDA has received dozens of adverse event reports, many of them serious, from consumers who used Reumofan Plus.  The reports include liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression, stroke, and even death.

Reumofan Plus and “WOW” products are sold on various websites, including Gonepainfree.com and Browerent.com. The products are manufactured by Riger Naturals S.A.  In addition to websites selling “WOW,” FDA has become aware that various websites, including Reumofanusa.com, owned by Reumofan USA, LLC, continue to sell Reumofan Plus even after previous FDA warnings. Please see the link to the FDA public warning for product photos.

RECOMMENDATION: Consumers currently taking or who have taken Reumofan Plus or “WOW” should immediately consult a health care professional.  Health care professionals are urged to ask their patients about the use of Reumofan Plus, “WOW,” and other similar products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, psychiatric changes, or the use or abrupt discontinuation of corticosteroids.
Additionally, health care professionals should evaluate patients who have used Reumofan Plus and/or WOW for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of Reumofan Plus products and “WOW” 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.

 

[12/19/2012 - FDA Public Warning - FDA]

Previous Related Safety Alert:
[08/21/2012 - Reumofan Plus MedWatch Safety Alert - FDA]


Reumofan Plus: Recall - Undeclared Drug Ingredient

[UPDATED 08/21/2012]

FDA is issuing an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared active ingredients found in prescription drugs that should be used only under the supervision of a health care professional.

Since June 1, 2012, when FDA first warned the public about the dangers of these supplements, the agency has received reports of fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome

Because of the possible risks, consumers should not buy or start using these products.

 

[Posted 06/01/2012]

ISSUE: FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful. An FDA laboratory analysis of Reumofan Plus found that it contains Diclofenac Sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines, and Methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.

FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. 

BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product. 

RECOMMENDATION: Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately. Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.


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:

 

[08/21/2012 - News Release - FDA]
[08/21/2012 - Consumer Update - FDA]
[06/01/2012 - News Release - FDA]  


Reumofan Plus: Recall - Undeclared Drug Ingredient

ISSUE: FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful. An FDA laboratory analysis of Reumofan Plus found that it contains Diclofenac Sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines, and Methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.

FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. 

BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product. 

RECOMMENDATION: Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately. Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.


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:


[06/01/2012 - News Release - FDA]  


American Regent Injectable Products: Recall - Visible Particulates in Products

  • Methyldopate HCL Injection, USP 5ml Single Dose Vial
  • Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial
  • Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial
  • Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials
  • Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL Multiple Dose Vials
  • Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages
  • Sodium Thiosulfate Injection USP 10%
  • Potassium Phosphates Injection, USP

 

[UPDATED 06/07/2011] Methyldopate HCL Injection, USP 5ml Single Dose Vial recalled.

[UPDATED 05/06/2011] Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial recalled.

[UPDATED 04/27/2011] Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial recalled.

[UPDATED 03/18/2011]  Dexamethasone Sodium Phosphate Injection products recalled.

[UPDATED 03/17/2011] Concentrated Sodium Chloride Injection products recalled.

[Posted 02/05/2011]

ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.

BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.

 

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:

 

[06/06/2011 - Press Release, Methyldopate HCL Injection - American Regent]
[05/05/2011 - Press Release, Caffeine & Sodium Benzoate Injection - American Regent]
[04/26/2011 - Press Release, Ammonium Molybdate Injection - American Regent]
[03/16/2011 - Press Release, Dexamethasone Sodium Phosphate - American Regent]
[03/15/2011 - Press Release, Bacteriostatic Sodium Chloride - American Regent] 
[03/15/2011 - Press Release, Concentrated Sodium Chloride - American Regent] 
[02/04/2011 - Press Release, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release, Potassium Phosphates - American Regent]   

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection]
[12/29/2010 - Sodium Bicarbonate Injection]


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