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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561
Recall Number D-1060-2013
Classification Class II
Code Info Lot #: 08022013@34, Exp11/3/2013
Product Distributed Qty 1 Vial
Reason For Recall 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.

Event Detail

Event Id 66198
Product Type Drugs
Status Terminated
Recalling Firm Northern New England Compounding Pharmacy LLC
City Littleton
State NH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-05
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern CT