Recalls / Class II

Class IID-0737-2017

Product

TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

Affected lot / code info

Lot # 11-18-2016@70, Exp 4/19/2017; 11-23-2016@84, Exp 5/22/2017; t12-14-2016@99, Exp 5/22/2017; t01-03-2017@94, Exp 6/18/2017; 01-13-2017@71, Exp 7/5/2017; 01-25-2017@103, Exp 7/5/2017; 02-06-2017@94, Exp 7/5/2017; t02-17-2017@87, Exp 8/2/2017.

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

200 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-0737-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.