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Recall Observatory FDA recall evidence

Drug product

Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.

D-1021-2013

September 06, 2013

Class II

Product summary

Firm
University Compounding Pharmacy
Event
Event 66206
Status
Terminated
Classification
Class II
Quantity
965.50 mL
Official record key
drug-enforcement:D-1021-2013

Official wording

Reason: Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.

Code information: Lot #s: 474323, Exp 9/13/2013; 498616, Exp 9/25/2013; 475475, Exp 9/26/2013.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility