Recalls / Class II
Class IID-0762-2023
Product
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
- Affected lot / code info
- Lot: NFG101, EXP: 1/31/2024; Lot: NFG102, EXP: 9/30/2024; Lot: NFG201, 5/31/2025
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Sagent Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 450, N/A, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 2,249,980 vials
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2023-05-19
- FDA classified
- 2023-05-23
- Posted by FDA
- 2023-05-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0762-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.