Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured b
FDA warns lab staff that use of BD SARS-CoV-2 Reagents for the BD Max System may lead to false positive results.
Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Dail
ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System.
Transliquid Technologies LLC is voluntarily recalling all Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level.
Arrow International is recalling the pumps because both devices have a part that may break, char, and discolor the motor connector wires.
UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)
Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). In response to a recent news alert by the Food and Drug Administration
On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health.
FDA warns lab staff and health care providers about using certain COVID-19 Serology/Antibody Tests.
GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups.
FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.
Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine
Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/da
Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the
FDA warns lab staff that exposure to cyanide gas may result from a reaction between transport media and testing platforms that are not compatible.
FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents.