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FDA MedWatch Alerts

FDA Label Changes are now available online and in our monthly newsletter update.

Convenience Kits containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate

December 9, 2016

Audience: Risk Manager. [Posted 12/09/2016] ISSUE: Centurion is recalling the Centurion Convenience Kits containing Multi-Med Single Lumen Catheters. The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process. If this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. This can result in serious a...

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Megajex Natural Male Sex Enhancer by MS Bionic: Recall - Undeclared Drug Ingredients

December 1, 2016

Audience: Consumer. [Posted 12/01/2016] ISSUE: MS Bionic, Inc. announced today that it is conducting a voluntary nationwide recall of all lots of Megajex Natural Male Sex Enhancer capsules. FDA analysis has found the product to contain Tadalafil and Sildenafil. Tadalafil and Sildenafil are FDA-approved drugs used as treatment for male Erectile Dysfunction (ED). The active drug ingredients are not listed on the...

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Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient

December 1, 2016

Audience: Consumer. [Posted 12/01/2016] ISSUE: Ultimate Body–Tox is voluntarily recalling all lots of Ultimate Body Tox PRO capsules to the consumer level. FDA analyses of this product found it to contain undeclared sibutramine. Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in Ultimate Body Tox PRO renders it an u...

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DMAA Net Weight 500g by NutriVitaShop: Recall - Presence of DMAA May Pose Health Risk

November 26, 2016

Audience: Consumer. [Posted 11/26/2016] ISSUE: NutriVitaShop, also doing business as Naturecom Inc. Lake Forest, CA is requesting the nationwide recall of its DMAA net weight 500g because there may be presence of DMAA. Lot numbers include #20141102, 20150715, 20151022, 20160226, 20160701, 20161017 and 20150323. DMAA net weight 500g is packaged in approximately 8" x 11” silver and clear mylar ziplock bags that c...

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Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall - Possible Belladonna Alkaloids

November 25, 2016

Audience: Consumer, Pharmacy, Pain management, Family Practice, Pediatrics. [Posted 11/25/2016] ISSUE: Raritan Pharmaceuticals, a contract manufacturer for Homeolab USA, is voluntarily recalling homeopathic products containing belladonna extract (see products below) due to the potential for variation in the content of belladonna extract in the products. The FDA has tested some products and recovered varying...

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Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance

November 21, 2016

Audience: Pharmacy. [Posted 11/21/2016] ISSUE: Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry due to FDA concerns over the lack of sterility assurance of the drugs named in this recall. Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in...

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Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance

November 21, 2016

Audience: Pharmacy. [Posted 11/21/2016] ISSUE: Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. See the press release for a listing of affected products and lot numbers. BACKGROUND: The recalled...

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GNC Women’s Ultra Mega Time Release 180 count Dietary Supplement by Nutra Manufacturing: Recall - Undeclared Milk

November 18, 2016

Audience: Consumer. [Posted 11/18/2016] ISSUE: Nutra Manufacturing, Inc. announced a nationwide, voluntary recall of one lot of GNC Women’s Ultra Mega Time Release dietary supplement product sold in 180 count containers UPC 048107158910, lot number 3044FQ2024, with an expiration date of June 2018 due to the fact the product may contain an undeclared major food allergen, milk. People who have an allergy or severe s...

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Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label Changes

November 15, 2016

Audience: Patient, Consumer, OBGYN, Risk Manager. ISSUE: Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure. The boxed warning includes safety statements to clearly communicate significant side effects ...

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Skinny Bee Diet by Love My Tru Body: Recall - Undeclared Drug Ingredients

November 8, 2016

Audience: Consumer. [Posted 11/08/2016] ISSUE: Love My Tru Body is voluntarily recalling all of Skinny Bee Diet 500 mg to the consumer level after FDA laboratory testing found Skinny Bee Diet to contain sibutramine, desmethylsibutramine, and/phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Desmethylsibutramine is an active metabolite of sibutramine....

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Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence

October 25, 2016

Audience: Patient, Endocrinology, Internal Medicine. ISSUE: FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS.  The Anabolic Steroids Control Act of ...

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Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating

October 4, 2016

Audience: Infectious Disease, Gastroenterology, Patient. ISSUE: The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver...

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Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children

September 30, 2016

Audience: Consumer. ISSUE: The FDA is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating...

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Sterile Products by Wells Pharmacy Network: Recall - Concern for Lack of Sterility Assurance

September 22, 2016

Audience: Pharmacy, Patient. [Posted 09/22/2016] ISSUE: Wells Pharmacy Network is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry due to FDA concern over a lack of sterility assurance. See the press release for a listing of affected prodcuts and lot numbers. Administration of a drug product intended to be...

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Hyoscyamine sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results

September 15, 2016

Audience: Pharmacy, Gastroenterology, Pulmonology, Patient. ISSUE: Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were manufactured by Pharmatech...

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GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe

September 9, 2016

Audience: Pharmacy, Patient. ISSUE: Novo Nordisk Inc. is recalling six batches of the GlucaGen HypoKit in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). A syringe with a detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. If...

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Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination

September 8, 2016

Audience: Consumers, Eye Care, Pharmacy. [Posted 09/08/2016] ISSUE:  United Exchange Corp. is voluntarily recalling specific lots of Family Care Eye Wash 4 oz due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight threatening eye infection. See the ...

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Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination

September 7, 2016

Audience: Consumers, Eye Care, Pharmacy. ISSUE: United Exchange Corp. of Cerritos, CA, a primary source vendor of the Rugby-branded Eye Irrigating Solution and Major-branded Eye Wash, is voluntarily recalling products due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a...

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Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use

September 7, 2016

Audience: Patient, OBGYN, Oncology. ISSUE: The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer. Despite extensive research and published studies, there are currently...

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Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring New Boxed Warnings About Serious Risks and Death

August 31, 2016

Audience: Pharmacy, Internal Medicine, Psychiatry, Neurology, Family Practice. ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths.  Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, ...

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