Edge Pharma EDTA Ophthalmic Solution Lacks Sterility Assurance
Edge Pharma, LLC is recalling Edetate Disodium (EDTA) 1.5% Sterile Ophthalmic Solution nationwide due to lack of assurance of sterility. The recalled product is a single-dose eye drop solution.
What this means for you
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: This is an FDA Class II recall. The source states a lack of assurance of sterility but does not report any illnesses, injuries, or confirmed contamination, making it a precautionary recall. No adverse events are documented in the source text.
Plain-English summary
Edge Pharma, LLC is recalling Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, with NDC 05446-1427-10, distributed nationwide.
The product is being recalled because there is a lack of assurance of sterility. Sterile ophthalmic solutions must meet strict sterility standards to prevent contamination when applied directly to the eye.
Consumers who have obtained this product should stop using it and contact Edge Pharma, LLC or their healthcare provider for guidance on return or disposal of the affected product. The recalled product was distributed nationwide.
The recalled product
- Product
- Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10
- 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)
- 10-2021-20@1 02/10/2022
Distribution
Distributed nationwide across the United States.
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