FDA Calls for Voluntary Withdrawal of Injectable Bacitracin

The FDA called on manufacturers of the bacitracin for injection to voluntarily withdraw their products from the market for safety concerns.

The potential problems associated with the injected form, including kidney harm and anaphylactic reactions, are “sufficiently serious to remove the drug from the market,” the agency said.

Bacitracin for injection is only approved to treat infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. The FDA’s Antimicrobial Drugs Advisory Committee last year rejected the use of the injectable antibiotic bacitracin for babies, finding that the risks outweighed the benefits for its only indication. 

The FDA said the voluntary withdrawal does not impact approved topical or ophthalmic products that contain bacitracin.