PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: August 2, 2023 Initiated: July 11, 2023 #D-0937-2023

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.

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Sagent Pharmaceuticals
Units Affected
760 bottles
Distribution
Nationwide in the USA
Location
Schaumburg, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sagent Pharmaceuticals. Units affected: 760 bottles.
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-0937-2023.