Recalls / Class II

Class IID-0708-2017

Product

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

Affected lot / code info

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.

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

6 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-0708-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.