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Recall Observatory FDA recall evidence

Drug product

Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41

D-0628-2023

May 15, 2023

Class II

Product summary

Firm
Astral SteriTech Private Ltd.
Event
Event 92341
Status
Terminated
Classification
Class II
Quantity
138,610 vials
Official record key
drug-enforcement:D-0628-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots within expiry.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility