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Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have
Author: FDA
Posted: September 17, 2020, 4:00 am
List of Medical Device recalls in 2020.
Author: FDA
Posted: September 16, 2020, 1:00 pm
The Alaris System is an infusion system. If parts of the PCA or Syringe Modules are damaged, incorrect syringe details may show, leading to inaccurate infusions.
Author: FDA
Posted: September 16, 2020, 4:00 am
The Alaris System is an infusion system. The PC Unit Keys may become stuck or unresponsive and may lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected device.
Author: FDA
Posted: September 14, 2020, 4:00 am
The Alaris System Infusion Pump is the foundation of the infusion system. Multiple models are being recalled due to damaged IUI Connectors, loose or missing Battery Screws and broken upper and lower hinge posts and membrane frame.
Author: FDA
Posted: September 14, 2020, 4:00 am
Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred v
Author: FDA
Posted: September 10, 2020, 4:00 am
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
Author: FDA
Posted: September 9, 2020, 11:00 am
The U.S. Food and Drug Administration (FDA) wants patients and health care providers to know about the risk of injury that may happen to patients if the cold-therapy mode of water-circulating hot/cold therapy devices is not used correctly.
Author: FDA
Posted: September 9, 2020, 4:00 am
The FDA has reviewed serious side effects associated with implanted spinal cord stimulators.
Author: FDA
Posted: September 3, 2020, 4:00 am
RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from six (6) lots by the U.S. Food and Drug Administration
Author: FDA
Posted: September 3, 2020, 4:00 am
Miami, Florida. AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications an
Author: FDA
Posted: September 3, 2020, 4:00 am
CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within expiry to the consumer level. The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bac
Author: FDA
Posted: September 3, 2020, 4:00 am
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System. Three of the situations described in this recall, which BD announced on June 30, 2020, have been designated as Cl
Author: FDA
Posted: September 1, 2020, 4:00 am
The Protein Shoppe, LLC is voluntarily recalling all lots of “Red-E” (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingred
Author: FDA
Posted: September 1, 2020, 4:00 am
Open Book Extracts (OBX) is voluntarily recalling to the consumer level all lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are labeled to contain methanol.
Author: FDA
Posted: August 31, 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 hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injec
Author: FDA
Posted: August 31, 2020, 4:00 am
Gowns purchased from Laws of Motion have potential quality issues and should not be used as personal protective equipment.
Author: FDA
Posted: August 28, 2020, 4:14 am
Guadalupe, Nuevo Leon, Harmonic Nature is voluntarily recalling all 800 bottles Hand Sanitizer, 250mL, product due to the potential presence of 1-propanol. The products have been tested and found to contain 1 propanol. Any amount of 1-propanol with a concentration greater than or equal to 1% by v
Author: FDA
Posted: August 28, 2020, 4:00 am
Based on FDA's review of new data from three clinical trials, the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing information was removed.
Author: FDA
Posted: August 26, 2020, 1:00 pm
Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL, Sanitizer gel, to the consumer level. FDA laboratory analysis found ZANILAST+ GEL to contain 1-propanol. There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system
Author: FDA
Posted: August 26, 2020, 4:00 am