D-0722-2017 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 total (10/1mL vials and 40/2mL vials)

Product Description

HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial.

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 # t01-17-2017@103, Exp 4/18/2017; t01-23-2017@80, Exp 4/24/2017; t02-10-2017@120, Exp 4/30/2017.