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Recall Observatory FDA recall evidence

Drug product

SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10

D-1294-2015

June 26, 2015

Class II

Product summary

Firm
The Apothecary Shoppe LLC
Event
Event 71618
Status
Terminated
Classification
Class II
Quantity
32.5 mL
Official record key
drug-enforcement:D-1294-2015

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 #: 04152015@6, BUD 10/12/2015; 03102015@41, BUD 07/08/2015

Distribution pattern: Oklahoma

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility