← FDA ENFORCEMENT
D-0937-2023Class 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
760 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.

Code / lot info

Lot: a) OXT202, exp 5/31/2025; OXT203, exp 5/31/2025; OXT301, exp 12/31/2025; b) OXT205, exp 6/30/2025; OXT204, exp 5/31/2025

Other recalls SPEQ maps to Environmental Monitoring
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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.