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
Product summary
- 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
Lack of Assurance of Sterility