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Recall Observatory FDA recall evidence

Drug product

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

May 19, 2023

Class II

Product summary

Firm
Sagent Pharmaceuticals Inc
Event
Event 92376
Status
Ongoing
Classification
Class II
Quantity
370,200 bottles
Official record key
drug-enforcement:D-0764-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: NFT101, EXP: 5/31/2024; Lots: NFT201, NFT202, EXP: 2/28/2025; Lots: NFT203, NFT204, EXP: 5/31/2025

Distribution pattern: Nationwide USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility