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Recall Observatory FDA recall evidence

Drug product

The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.

D-1066-2014

April 15, 2013

Class II

Product summary

Firm
Apothecure, Inc
Event
Event 64921
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-1066-2014

Official wording

Reason: Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.

Code information: All Lots

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility