Edge Pharma Phenylephrine/Tropicamide Ophthalmic Solution Sterility Recall
Edge Pharma is recalling a sterile ophthalmic solution (Phenylephrine HCl/Tropicamide 2.5%/1%) because the manufacturer cannot assure sterility of the product. The recall affects 363 droptainers distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile ophthalmic solution with loss of sterility assurance, which represents a significant risk of eye infection. No illnesses or injuries are reported in the source text, but the hazard (infection from non-sterile eye drops) poses clear risk of harm to patients using the product for direct ocular application.
Plain-English summary
Edge Pharma, LLC is recalling Phenylephrine HCl/Tropicamide Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper in a Multiple Dose Droptainer for topical ophthalmic use (NDC 05446-0815-01). The affected lot is 09-2021-15@1 with expiration date 12/28/2021, totaling 363 droptainers.
The recall was initiated due to lack of assurance of sterility. A sterile ophthalmic solution that is not sterile poses a risk of infection when applied to the eye.
The product was distributed nationwide. Patients who have received or are using this product should contact their healthcare provider or pharmacist for guidance. Consumers should not use the affected product.
The recalled product
- Product
- Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 363
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)
- 09-2021-15@1 12/28/2021
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.
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