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Recall Observatory FDA recall evidence

Drug product

SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18

D-1305-2015

June 26, 2015

Class II

Product summary

Firm
The Apothecary Shoppe LLC
Event
Event 71618
Status
Terminated
Classification
Class II
Quantity
555.5 mL
Official record key
drug-enforcement:D-1305-2015

Official wording

Reason: Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Code information: Lot #s: 04062015@30, BUD: 09/01/2015; 04172015@20, BUD: 10/14/2015

Distribution pattern: Oklahoma

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility