Recalls / Class II
Class IID-0937-2023
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.
- Affected lot / code 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Sagent Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 450, N/A, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 760 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-11
- FDA classified
- 2023-07-21
- Posted by FDA
- 2023-08-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0937-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.