Bedford Pharmacy Recalls Hydroxocobalamin Injection Due to Sterility Concerns
Bedford Pharmacy is recalling Hydroxocobalamin 20 mg/mL Injection due to a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.
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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential health consequences such as sterility issues in injectable drugs.
Plain-English summary
Bedford Pharmacy is recalling Hydroxocobalamin 20 mg/mL Injection, 1 vial, due to a lack of assurance of sterility. The recall involves Lot # 08042015@3 with an expiration date of 09/18/2015.
The product was distributed in New Hampshire and Massachusetts. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the recalled product and contact Bedford Pharmacy at (603) 472-3919 for further instructions or a return.
The recalled product
- Product
- Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
- Manufacturer
- Bedford Pharmacy
- Category
- Drug — Injection
- Hazard
- 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 #: 08042015@3
- Exp 09/18/2015
Distribution
Part of a larger recall action
This product is one of 13 recalled by Bedford Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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