Drug recall D-0937-2023

Class II Ongoing reported Aug 2, 2023

Product

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.

Reason for recall

Lack of Assurance of Sterility

Lots and codes

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

Recall details

Recalling firm
Sagent Pharmaceuticals, Schaumburg, IL
Quantity
760 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
July 11, 2023