Sterile Ophthalmic Solution Lacks Assurance of Sterility
Edge Pharma is recalling a sterile ophthalmic solution due to lack of assurance of sterility. The recall affects 2,562 syringes 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 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 FDA classified this as a Class II recall. Lack of sterility assurance in an ophthalmic solution poses a significant risk of serious infection if administered to the eye, qualifying it as a severe hazard per the rubric criterion for Class II recalls with risk of serious injury.
Plain-English summary
Edge Pharma, LLC is recalling Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL single-use syringes (NDC 05446-0993-01) due to lack of assurance of sterility.
The recalled product consists of 2,562 syringes with lot codes 09-2021-15@2 (dated 12/28/2021) and 11-2021-02@3 (dated 02/14/2022) that were distributed nationwide. The ophthalmic solution is intended for topical eye use.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance. Patients should not use the recalled syringes and should return them to the point of purchase or contact Edge Pharma for instructions.
The recalled product
- Product
- Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 2,562
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@2 12/28/2021 & 11-2021-02@3 02/14/2022
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.
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