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…
Camber Pharmaceuticals Issues Voluntary Recall of Montelukast Tablets
The FDA is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets lot number MON17384, expiration 12/31/2019 by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg. This…
Labeling Mix-Up: Accord Healthcare Issues Voluntary Recall of Hydrochlorothiazide Tablets
Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level. A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is…
Pfizer Issues Voluntary Nationwide Recall of one Lot of Children’s Advil
Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL). Pfizer concluded that the use of the product with an unmatched dosage…
FDA Alerts Drug Makers of a Recall of Porcine Thyroid API
FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API due to inconsistent quality of the API. FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015. This thyroid…
Torrent Pharmaceuticals Issues Voluntary Nationwide Recall
Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in…
Pharmaceutical Recalls Down, Medical Device Recalls Up In 2Q
In the second quarter of 2018, pharmaceutical recalls dropped 27 percent to 77, which is lower than six of the last eight quarters, while recalled units dropped 95 percent to nearly 15.9 million, but in line with the recent average quarter (2013-2016), according to the latest U.S. Recall Index released August 8 by Stericycle Expert Solutions. The Recall Index covers recalls…