FDAClass IIDecember 17, 2014

Cyanocobalamin Injection recall: Sterility Concern

CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC…

Why was Cyanocobalamin Injection recalled?

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

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?

Lot 6003853, exp. date 04/2014

Product
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC…
Recalling firm
Fresenius Kabi USA, LLC
Quantity
240,550 Vials
Distribution
U.S. Nationwide Including Puerto Rico
Recall date
December 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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