Antibiotic Injection Recalled

A lack of assurance of sterility has prompted Sagent Pharmaceuticals to recall 65,710 vials and 760 bulk bottles containing oxacillin for injection, according to the August 2, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured in India for Sagent Pharmaceuticals, Schaumburg, Illinois, and distributed throughout the United States:

• oxacillin for injection, 1 gram per vial (NDC 25021-146-10), from lot OXG301 (Exp 12/31/25);
• oxacillin for injection, 2 grams per vial (NDC 25021-162-24), from lots OXL202 (Exp 6/30/25), OXL204 (Exp. 6/30/25), OXL301 (Exp. 12/31/25), and OXL205 (Exp. 11/30/25);
• oxacillin for injection, 2 grams per vial, labeled as novaplus (NDC 25021-162-68), from lots OXL201 (Exp 5/31/25) and OXL203 (Exp 6/30/25);
• oxacillin for injection, 10 gram per pharmacy bulk package bottle (NDC 25021-163-99), from lots OXT202 (Exp 5/31/25), OXT203 (Exp 5/31/25), and OXT301 (Exp 12/31/25); and
• oxacillin for injection, 10 gram per pharmacy bulk package bottle, labeled as novaplus (NDC 25021-163-68), from lots OXT205 (Exp 6/30/25) and OXT204 (Exp 5/31/25).

Sagent Pharmaceuticals voluntarily initiated the recall July 11, 2023. On July 21, 2023, the FDA designated it Class II, signaling use of the affected product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Oxacillin for injection is an antibiotic for intramuscular or intravenous use in patients with infections caused by certain bacteria.