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Recall Observatory FDA recall evidence

Drug product

SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

D-0781-2017

April 18, 2017

Class II

Product summary

Firm
Key Pharmacy and Compounding Center
Event
Event 76912
Status
Terminated
Classification
Class II
Quantity
91 vials
Official record key
drug-enforcement:D-0781-2017

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 # t12-19-2016@76, Exp 4/27/2017; t11-28-2016@114, Exp 5/28/2017; t11-29-2016@102, Exp 5/29/2017; t12-06-2016@98, Exp 6/6/2017; t12-22-2016@118, Exp 6/21/2017; t12-22-2016@119, Exp 6/21/2017; t02-06-2017@98, Exp 8/6/2017; t02-07-2017@60, Exp 8/7/2017; t02-21-2017@109, Exp 08/21/2017

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