Bedford Pharmacy Recalls Acetylcysteine 10% Ophthalmic Solution Due to Sterility Concerns
Bedford Pharmacy is recalling two bottles of Acetylcysteine 10% Ophthalmic Solution because there is a lack of assurance of 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, which corresponds to a Severe severity score under the rubric for drug recalls.
Plain-English summary
Bedford Pharmacy is recalling two bottles of Acetylcysteine 10% Ophthalmic Solution. The recall was initiated due to a lack of assurance of sterility in the product.
The affected product is identified by Lot # 07232015@1 and has an expiration date of 09/06/29015. The product was distributed in New Hampshire and Massachusetts.
Consumers who have this product should stop using it and contact Bedford Pharmacy at (603) 472-3919 for further instructions.
The recalled product
- Product
- Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
- Manufacturer
- Bedford Pharmacy
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 2
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 #: 07232015@1
- Exp 09/06/29015
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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