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…
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…