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Recall Observatory FDA recall evidence

Drug product

PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass; Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0775-2017

April 18, 2017

Class II

Product summary

Firm
Key Pharmacy and Compounding Center
Event
Event 76912
Status
Terminated
Classification
Class II
Quantity
1 vial
Official record key
drug-enforcement:D-0775-2017

Official wording

Reason: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information: Lot t# 02-14-2017@102, Exp 5/1/2017

Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility