December 20, 2019
AuroMedics Pharma is recalling more than 275,000 vials containing vancomycin hydrochloride for injection due to complaints of discoloration after reconstitution. The recall was included in the December 18, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects vancomycin hydrochloride for injection, 1 gram per vial, 10 vials per carton (NDC 55150-204-20) from the following lots: CVM180003 and CVM180004 (Exp. 4/20), CVM180008 (Exp. 7/20), and CVM180009, CVM180010, CVM180011, and CVM180012 (Exp. 9/20). The recalled product was distributed throughout the United States.
AuroMedics Pharma voluntarily initiated the recall November 25, 2019. The FDA designated the recall Class II on December 6, 2019. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Vancomycin is a prescription antibiotic used to treat serious bacterial infections.