PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: August 2, 2023 Initiated: July 11, 2023 #D-0936-2023

Product Description

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

Details

Recalling Firm
Sagent Pharmaceuticals
Units Affected
65,710 vials for 1 g and 2 g strength
Distribution
Nationwide in the USA
Location
Schaumburg, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sagent Pharmaceuticals. Units affected: 65,710 vials for 1 g and 2 g strength.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on August 2, 2023. Severity: Moderate. Recall number: D-0936-2023.