Recalls / Class II

Class IID-0781-2017

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

Affected lot / code info

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

Why it was recalled

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

Recalling firm

Firm

Key Pharmacy and Compounding Center

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

530 S 336th St, Federal Way, Washington 98003-6383

Distribution

Quantity

91 vials

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

Timeline

Recall initiated

2017-04-18

FDA classified

2017-05-17

Posted by FDA

2017-05-24

Terminated

2017-08-29

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0781-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.