Antibiotic Bags Recalled

New England Life Care Inc, which does business as Advanced Compounding Solutions, is recalling 209 bags of vancomycin hydrochloride due to Current Good Manufacturing Practice violations. According to the July 26, 2023, US Food and Drug Administration (FDA) Enforcement Report, “spaces adjacent to the production area may have been compromised at the time of production.” No further details were provided.

The recall affects vancomycin hydrochloride 1.5 g added to 0.9% sodium chloride 500 mL, packaged in 500-mL IV bags (515 total volume, NDC 71546-310-50), from lot 20230524-0113AB (Exp 8/22/23). The product was distributed throughout the United States.

New England Life Care voluntarily initiated the recall July 10, 2023. On July 19, 2023, the FDA designated it Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Vancomycin hydrochloride is a prescription antibiotic used in the treatment of bacterial infections.