CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Pr...

FDA Recall #D-0761-2017 — Class II — April 18, 2017

Recall #D-0761-2017 Date: April 18, 2017 Classification: Class II Status: Terminated

Product Description

CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple 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.

Recalling Firm

Key Pharmacy and Compounding Center — Federal Way, WA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2 vials

Distribution

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

Code Information

Lot # t02-13-2017@99, Exp 5/15/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated