FDAClass IISeptember 25, 2013

Hydroxocobalamin MDV 5 mg/mL recall: Sterility Concern

Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561

Why was Hydroxocobalamin MDV 5 mg/mL recalled?

Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed sterility results by a third party contract testing lab. Hence the sterility of the product cannot be assured.

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 #: 08022013@34, Exp11/3/2013

Product
Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561
Recalling firm
Northern New England Compounding Pharmacy LLC
Quantity
1 Vial
Distribution
CT
Recall date
September 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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