Recalls / Class II

Class IID-0710-2017

Product

5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

Affected lot / code info

Lot # t12-05-2016@116, Exp 6/4/2017; t12-15-2016@84, Exp 6/14/2017; t12-23-2016@67, Exp 6/25/2017; t12-28-2016@105, Exp 6/27/2017; t01-30-2017@88, Exp 7/30/2017; t02-06-2017@109, Exp 8/6/2017; t02-14-2017@92, Exp 8/14/2017; t02-20-2017@79, Exp 8/20/2017

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

63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)

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-0710-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.