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Recall Observatory FDA recall evidence

Drug product

SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.

D-66241-002

September 06, 2013

Class II

Product summary

Firm
Apothecary Shoppe
Event
Event 66241
Status
Terminated
Classification
Class II
Quantity
1,430 mL
Official record key
drug-enforcement:D-66241-002

Official wording

Reason: Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory

Code information: Lot #s: 05132013@25, Exp 11/9/13; 08072013@4, Exp 2/3/14

Distribution pattern: Oklahoma

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility