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Recall Observatory FDA recall evidence

Drug product

Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10

D-0762-2023

May 19, 2023

Class II

Product summary

Firm
Sagent Pharmaceuticals Inc
Event
Event 92376
Status
Ongoing
Classification
Class II
Quantity
2,249,980 vials
Official record key
drug-enforcement:D-0762-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: NFG101, EXP: 1/31/2024; Lot: NFG102, EXP: 9/30/2024; Lot: NFG201, 5/31/2025

Distribution pattern: Nationwide USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility