Why it was recalled
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.
Product description
Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561
Lot numbers, UPCs & expiration codes
Lot #: 08022013@34, Exp11/3/2013
Where it was sold
CT
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1060-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 5, 2013
- FDA report date
- Sep 25, 2013
- Quantity
- 1 Vial
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Northern New England Compounding Pharmacy LLC
Original FDA data
Every field from FDA enforcement report D-1060-2013, exactly as published.
Show all FDA fields
- City
- Littleton
- State
- NH
- Status
- Terminated
- Country
- United States
- Event ID
- 66198
- Address
- 262 Cottage St Ste 116
- Code information
- Lot #: 08022013@34, Exp11/3/2013
- Postal code
- 03561-4143
- Report date
- Sep 25, 2013
- Product type
- Drugs
- Recall number
- D-1060-2013
- Classification
- Class II
- Recalling firm
- Northern New England Compounding Pharmacy LLC
- Product quantity
- 1 Vial
- Termination date
- Sep 17, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561
- Distribution pattern
- CT
- Recall initiation date
- Sep 5, 2013
- Initial firm notification
- Telephone
- Center classification date
- Sep 17, 2013