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Recall Observatory FDA recall evidence

Drug product

TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial , Prepared by Key Compounding Pharmacy

D-0745-2017

April 18, 2017

Class II

Product summary

Firm
Key Pharmacy and Compounding Center
Event
Event 76912
Status
Terminated
Classification
Class II
Quantity
17 vials
Official record key
drug-enforcement:D-0745-2017

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 # t12-07-2016@97, Exp 5/22/2017; t12-12-2016@88, Exp 5/22/2017; t12-20-2016@109, Exp 5/22/2017; t12-20-2016@119, Exp 6/18/2017; t12-23-2016@63, Exp 6/18/2017; t12-30-2016@84, Exp 6/18/2017; t01-09-2017@97, Exp 6/18/2017; t12-22-2016@120, Exp 6/18/2017; t02-07-2017@72, Exp 8/2/2017

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