Hydroxocobalamin Injection Recalled Due to Failed Sterility Testing
Northern New England Compounding Pharmacy is recalling one lot of Hydroxocobalamin Injection because third-party testing failed to confirm sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Northern New England Compounding Pharmacy LLC is recalling one lot of Hydroxocobalamin MDV 5 mg/mL Injection, 10 mL vial. The product was distributed in Connecticut.
The recall was initiated because a third-party contract testing laboratory reported failed sterility results for the product. Consequently, the sterility of the medication cannot be assured.
Consumers who possess this specific lot of Hydroxocobalamin Injection should discontinue use and contact their healthcare provider or the recalling pharmacy for further instructions.
The recalled product
- Product
- Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561
- Manufacturer
- Northern New England Compounding Pharmacy LLC
- Category
- Drug — Injectable
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 08022013@34
- Exp11/3/2013
Distribution
Distributed in 1 state:
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