Recalls / Class II
Class IID-0935-2023
Product
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
- Affected lot / code info
- Lot: OXG301, Exp 12/31/2025
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
- 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-0935-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.