Walter's Pharmacy Recalls Edetate Disodium Eye Drops Due to Sterility Concerns
Walter's Pharmacy is recalling specific lots of Edetate Disodium 2% Ophth Solution because the sterility of the product cannot be assured.
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 the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in an ophthalmic product) fall under the Severe category.
Plain-English summary
Walter's Pharmacy is recalling Edetate Disodium 2% Ophth Solution, 15mL bottles, prescription only. The recall is being conducted because there is a lack of assurance of sterility for the affected product.
The recalled product is identified by NDC 99999-9019-47 and includes Lot #012116 and #012516. The distribution was limited to Pennsylvania.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
- 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 (2)
- Lot #: 012116
- #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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