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HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple ...

FDA Recall #D-0725-2017 — Class II — April 18, 2017

Recall #D-0725-2017 Date: April 18, 2017 Classification: Class II Status: Terminated

Product Description

HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,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

7 vials total (1/5mL vial and 6/30 mL vials)

Distribution

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

Code Information

Lot # t01-26-2017@98, Exp 4/27/2017; t02-06-2017@108, Exp 4/30/2017.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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