Walter's Pharmacy Recalls Silver Nitrate Ophthalmic Solution Due to Sterility Concerns
Walter's Pharmacy is recalling Silver Nitrate 1% Ophthalmic Solution due to a lack of assurance of sterility. The product is distributed in Pennsylvania.
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. According to the rubric, an FDA Class II recall with potential for adverse health consequences (infection due to lack of sterility) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High (3) due to the specific agency classification and risk of harm.
Plain-English summary
Walter's Pharmacy is recalling Silver Nitrate 1% Ophthalmic Solution, 5mL bottles, due to a lack of assurance of sterility. The recall involves Lot #012516, which is identified by NDC 99999-9991-92. The product is prescription-only and was distributed in Pennsylvania.
The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific hazard cited is the lack of assurance of sterility, which poses a risk of infection if the product is used.
Consumers who have this product should stop using it and contact their healthcare provider or Walter's Pharmacy at 610-435-4706 for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92
- Manufacturer
- Walter's Pharmacy
- Category
- Drug — Ophthalmic Solution
- 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 (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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