Enforcement Report - Week of June 7, 2023
Enforcement Report - Week of January 25, 2023
[1/31/2020] The U.S. Food and Drug Administration has requested that all current manufacturers of bacitracin for injection voluntarily withdraw their product from the market. Bacitracin for injection is currently FDA-approved to treat infants with pneumonia and empyema (a collection of pus in the space between the membranes lining the lungs) caused by staphylococci, a type of bacteria, shown to be susceptible to the drug. However, health care professionals no longer use bacitracin for injection to treat this condition because other effective FDA-approved treatments are available that do not have the same serious risks, including nephrotoxicity (harm to the kidneys), anaphylactic reactions and the need for repeated intramuscular injections.
The US Food and Drug Administration (FDA) on Friday requested that all current manufacturers of bacitracin for injection voluntarily withdraw their products from the market.
Health Canada Issues Recalls Kit Care Corporation`s Safetec Triple Antibiotic Ointment
Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products
Enforcement Report - Week of April 24, 2019
Enforcement Report - Week of October 24, 2018
Akorn’s Generic Bacitracin Receives Approval In US