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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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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

Product Detail

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