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Recall Observatory FDA recall evidence

Drug product

DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy

D-0714-2017

April 18, 2017

Class II

Product summary

Firm
Key Pharmacy and Compounding Center
Event
Event 76912
Status
Terminated
Classification
Class II
Quantity
214 vials
Official record key
drug-enforcement:D-0714-2017

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 # t12-16-2016@73, Exp 4/18/2017; t12-27-2016@93, Exp 4/27/2017; t01-09-2017@102, Exp 5/10/2017; t01-10-2017@120, Exp 5/11/2017; 02-01-2017@78, Exp 6/1/2017; t02-08-2017@96, Exp 6/9/2017; t02-20-2017@80, Exp 6/21/2017; t02-21-2017@122, Exp 6/23/2017; t02-23-2017@68, Exp 6/24/2017.

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