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Recall Observatory FDA recall evidence

Drug product

SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34

D-1291-2015

June 26, 2015

Class II

Product summary

Firm
The Apothecary Shoppe LLC
Event
Event 71618
Status
Terminated
Classification
Class II
Quantity
1200.4 mL
Official record key
drug-enforcement:D-1291-2015

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 #: 04142015@5, BUD 8/12/2015; 04032015@23, BUD 7/2/2015; 04242015@28, BUD 8/22/2015

Distribution pattern: Oklahoma

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility