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Recall Observatory FDA recall evidence

Drug product

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

D-1060-2013

September 05, 2013

Class II

Product summary

Firm
Northern New England Compounding Pharmacy LLC
Event
Event 66198
Status
Terminated
Classification
Class II
Quantity
1 Vial
Official record key
drug-enforcement:D-1060-2013

Official wording

Reason: 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.

Code information: Lot #: 08022013@34, Exp11/3/2013

Distribution pattern: CT

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility