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Recall Observatory FDA recall evidence

Drug product

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75

D-0594-2023

May 15, 2023

Class II

Product summary

Firm
Astral SteriTech Private Ltd.
Event
Event 92341
Status
Terminated
Classification
Class II
Quantity
35,087 bottles
Official record key
drug-enforcement:D-0594-2023

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