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Recall Observatory FDA recall evidence

Drug product

SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10

D-1296-2015

June 26, 2015

Class II

Product summary

Firm
The Apothecary Shoppe LLC
Event
Event 71618
Status
Terminated
Classification
Class II
Quantity
70 mL
Official record key
drug-enforcement:D-1296-2015

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: 03102015@30, BUD 7/8/2015; 04162015@30, BUD 10/13/2015

Distribution pattern: Oklahoma

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility