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Recall Observatory FDA recall evidence

Drug product

5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0708-2017

April 18, 2017

Class II

Product summary

Firm
Key Pharmacy and Compounding Center
Event
Event 76912
Status
Terminated
Classification
Class II
Quantity
6 vials
Official record key
drug-enforcement:D-0708-2017

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 # t11-17-2016@86, Exp 5/17/2017; t12-22-2016@103, Exp 7/4/2017; t01-09-2017@111, Exp 7/9/2017; t01-11-2017@118, Exp 7/11/2017; t01-18-2017@89, Exp 7/18/2017; t01-20-2017@83, Exp 7/23/2017.

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