Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0400-2022·Announced 2022-02-02

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.

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: 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
Affected units: 80

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.

Part of a larger recall action

This product is one of 56 recalled by Edge Pharma, LLC 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.

See all 56 products in this recall →

Same manufacturer · Edge Pharma, LLC

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