← FDA ENFORCEMENT
D-0935-2023Class II

Sagent Pharmaceuticals

Recalling firm
Sagent Pharmaceuticals
Product type
Drug
Status
Ongoing
Report date
2023-08-02
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
65,710 vials for 1 g and 2 g strength
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.

Code / lot info

Lot: OXG301, Exp 12/31/2025

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IArgon Medical Devices, Inc2026-07-22Class IIOlympus Corporation of the Americas2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.