FDAClass IIJune 5, 2013

Hydroxycobalamin Inj 1 mcg/ml MDV recall: Sterility Concern

Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,

Why was Hydroxycobalamin Inj 1 mcg/ml MDV recalled?

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

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 products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Product
Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
Recalling firm
Nora Apothecary and Alternative Therapies, Inc.
Quantity
N/A
Distribution
Nationwide
Recall date
June 5, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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