Mylan Pharmaceuticals is conducting a voluntary nationwide recall of select lots of Valsartan-containing products due to trace amounts of an impurity, N-nitrosodiethylamine (NDEA), contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human…
Drug Recalls Increased, Medical Device Recalls Decreased in Q3
In the third quarter of 2018, faulty manufacturing practices had an impact on the pharmaceutical industry, according to the latest Recall Index released November 13 by Stericycle Expert Solutions. Drug recalls increased 19 percent to 92, though recalled units declined 56 percent to just over 7 million; lower than 10 of the last 13 quarters. Failed specifications…
FDA Alerts Consumers of Voluntary Recall of Puriton Eye Relief Drops
The Food and Drug Administration is alerting consumers about a voluntary recall of all lots of Puriton Eye Relief Drops, 0.5 oz. (15 ml) bottle. These products are labeled as a homeopathic and are being recalled due to non-sterile production conditions at the manufacturing facility. Consumers should stop using this product and contact their physician or…
FDA Update: Angiotensin II Receptor Blocker Recalls
FDA is alerting patients and health care professionals to ScieGen’s voluntary recall of certain lots of irbesartan, an angiotensin II receptor blocker (ARB), because they contain N-Nitrosodiethylamine (NDEA), a known animal and suspected human carcinogen (causes cancer). FDA laboratory testing confirmed NDEA in some lots of ScieGen’s irbesartan. ScieGen’s irbesartan products are labeled as Westminster Pharmaceuticals and…
After Recall, FDA Investigates the Presence of Impurities in Valsartan Products
FDA continues to investigate the presence of impurities in valsartan products and other angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure. FDA recently identified the impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in certain valsartan products. FDA is posting its test results showing NDMA levels in recalled valsartan products. FDA…
FDA Approves Genentech’s Xolair Prefilled Syringe Formulation
Genentech, a member of the Roche Group received FDA approval for 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications. The new Xolair PFS formulation is expected to be available by the end of this year for the…
Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin
Endo Pharmaceuticals is voluntarily recalling two lots of Robaxin (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as “two to four tablets four times daily” rather than the…
BioLyte Laboratories Issues Voluntary Recall of NeoRelief
The FDA is alerting consumers and health care professionals about a voluntary recall of certain lots (1138, 1139, 1146, and 1160) of NeoRelief distributed by BioLyte Laboratories (Grand Rapids, Michigan). NeoRelief is labeled as a homeopathic topical for the temporary relief of occasional muscle cramps, restlessness and twitching and is being recalled due to microbial contamination at…
FDA Provides Update on Ongoing Investigation into Valsartan Products
The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recall of several drug products containing the active pharmaceutical ingredient (API) valsartan, used to treat high blood pressure and heart failure. The FDA’s latest testing of products shows an additional unexpected impurity in three lots of Torrent…
Beaumont Bio Med Issues Voluntary Recall of all Homeopathic Aqueous/Alcohol-Based Medicines
Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination. The administration or use of drug products with microbial contamination could potentially result in increased infections that…