Edge Pharma Edetate Disodium Ophthalmic Solution Recall for Sterility Concerns
Edge Pharma is recalling Edetate Disodium (EDTA) 3% Sterile Ophthalmic Solution due to lack of assurance of sterility. The product is a single-dose eye drop used for topical ophthalmic use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard—lack of sterility assurance in a product applied directly to a sensitive organ (the eye)—presents significant risk of serious infection or injury, even though no illnesses have been reported in the source text. This meets the Severe threshold for FDA Class II recalls with risk of serious health consequences.
Plain-English summary
Edge Pharma, LLC is recalling Edetate Disodium (EDTA), Sterile Ophthalmic Solution, 3%, supplied in 10mL single-dose Droptainers for topical ophthalmic (eye) use. The product is manufactured by Edge Pharma, LLC at their facility in Colchester, Vermont.
The recall is due to lack of assurance of sterility. Because this is a sterile ophthalmic solution intended for direct application to the eye, any loss of sterility assurance poses a significant risk to patients.
The product has been distributed nationwide. Consumers who have received this product should stop use and consult their healthcare provider for guidance on next steps. Healthcare providers and patients should contact Edge Pharma, LLC or the FDA with any questions or to report adverse events.
The recalled product
- Product
- Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1428-10
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Solution
- Hazard
- sterility-assurance
- contamination-risk
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)
- 09-2021-22@1 01/04/2022
Distribution
Distributed nationwide across the United States.
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