Walter's Pharmacy Recalls Rose Bengal 1% Ophthalmic Solution Due to Sterility Concerns
Walter's Pharmacy is recalling three bottles of Rose Bengal 1% Ophthalmic Solution because the agency could not ensure the product was sterile.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Walter's Pharmacy is recalling three bottles of Rose Bengal 1% Ophthalmic Solution, 5mL, prescription only. The recall was initiated because the company could not provide assurance that the product was sterile.
The affected product is identified by Lot # 012516. The recall is limited to Pennsylvania, where the pharmacy is located at 401 N 17th St., Allentown, PA.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706
- Manufacturer
- Walter's Pharmacy
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 3
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 (1)
- Lot #: 012516
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 13 recalled by Walter's 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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