Recalls / Class II
Class IID-0936-2023
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.
- Affected lot / code info
- 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
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
- 65,710 vials for 1 g and 2 g strength
- 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-0936-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.