D-0721-2017 Class II Terminated

Recalled by Key Pharmacy and Compounding Center — Federal Way, WA

Recall Details

Product Type
Drugs
Report Date
May 24, 2017
Initiation Date
April 18, 2017
Termination Date
August 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50 vials

Product Description

HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot # t01-16-2017@91, Exp 4/17/2017; t02-08-2017@93, Exp 4/30/2017.