Follow us:

MedWatch Safety Alerts

MedWatch Safety Alerts RSS Feed

4e Brands North America is voluntarily recalling ten (10) bottle sizes of Hand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)
Author: FDA
Posted: July 13, 2020, 4:00 am
Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been c
Author: FDA
Posted: July 8, 2020, 4:00 am
As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the
Author: FDA
Posted: July 8, 2020, 4:00 am
Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches wer
Author: FDA
Posted: July 8, 2020, 4:00 am
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

Author: FDA
Posted: July 7, 2020, 4:00 am
The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System.
Author: FDA
Posted: July 6, 2020, 4:00 am
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).
Author: FDA
Posted: July 6, 2020, 4:00 am
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
Author: FDA
Posted: July 6, 2020, 4:00 am
FDA warns lab staff that use of BD SARS-CoV-2 Reagents for the BD Max System may lead to false positive results.
Author: FDA
Posted: July 6, 2020, 4:00 am
List of Medical Device recalls in 2020.
Author: FDA
Posted: July 2, 2020, 1:00 pm
Arrow International is recalling the pumps because both devices have a part that may break, char, and discolor the motor connector wires.
Author: FDA
Posted: July 2, 2020, 4:00 am
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.
Author: FDA
Posted: July 2, 2020, 4:00 am
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)
Author: FDA
Posted: June 29, 2020, 4:00 am
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
Author: FDA
Posted: June 27, 2020, 4:00 am
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.
Author: FDA
Posted: June 24, 2020, 4:00 am
FDA warns lab staff and health care providers about using certain COVID-19 Serology/Antibody Tests.
Author: FDA
Posted: June 19, 2020, 4:00 am
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.
Author: FDA
Posted: June 18, 2020, 4:00 am
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.
Author: FDA
Posted: June 15, 2020, 9:00 pm
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
Author: FDA
Posted: June 11, 2020, 4:00 am
The FDA is concerned that certain respirators from China may not provide adequate protection to health care personnel based on testing by CDC NIOSH.
Author: FDA
Posted: June 7, 2020, 4:00 am