Drug recall D-0936-2023

Class II Ongoing reported Aug 2, 2023

Product

Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.

Reason for recall

Lack of Assurance of Sterility

Lots and codes

Lot #: a) OXL202, exp 6/30/2025; OXL204, exp 6/30/2025; OXL301, exp 12/31/2025; OXL205, exp 11/30/2025; b) OXL201, exp 5/31/2025; OXL203, exp 6/30/2025

Recall details

Recalling firm
Sagent Pharmaceuticals, Schaumburg, IL
Quantity
65,710 vials for 1 g and 2 g strength
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
July 11, 2023