Recalls / Class II

Class IID-0763-2017

Product

FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

Affected lot / code info

Lot # t02-13-2017@98, Exp 5/15/2017; t02-14-2017@98, Exp 5/16/2017; t02-15-2017@120, Exp 5/17/2017

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

3 vials total (2/5mL vials and 1/10mL)

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-0763-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.