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Recall Observatory FDA recall evidence

Drug product

All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX

D-1564-2014

December 19, 2013

Class II

Product summary

Firm
Abrams Royal Pharamacy
Event
Event 67135
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1564-2014

Official wording

Reason: Lack of Assurance of Sterility

Code information: All unexpired lots of sterile drug products

Distribution pattern: Nationwide and to Canada

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility