Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99

FDA recall notice · announced May 31, 2023 · Sagent Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99

Reason for recall

Lack of Assurance of Sterility

Notes

Distribution: Nationwide USA
Lot/code information: Lot: NFT101, EXP: 5/31/2024; Lots: NFT201, NFT202, EXP: 2/28/2025; Lots: NFT203, NFT204, EXP: 5/31/2025
Quantity: 370,200 bottles
Status: Ongoing
Products in this recall event:
- Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10 (D-0763-2023)
- Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10 (D-0762-2023)
- Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99 (D-0764-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.