FDAClass IIAugust 13, 2014

Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 recall

Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.

Why was Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 recalled?

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lot numbers and exp dates

Product
Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Recalling firm
Medical Supply Liquidators Llc
Quantity
N/A
Distribution
Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.
Recall date
August 13, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls