Status
Terminated
Drug Enforcement D-1060-2013
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.
Classification
Class II
Report Date
September 25, 2013
Termination Date
September 17, 2013
Product Information
- Product description
- Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- CT
Location & Firm
- Recalling firm
- Northern New England Compounding Pharmacy LLC
- Address
-
262 Cottage St Ste 116, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1060-2013
- Event ID
- 66198
- Recall initiation date
- September 5, 2013
- Center classification date
- September 17, 2013
- Code info
- Lot #: 08022013@34, Exp11/3/2013
- More code info
- —