Edge Pharma Phenylephrine/Lidocaine Ophthalmic Solution Sterility Recall
Edge Pharma is recalling Phenylephrine HCl/Lidocaine sterile ophthalmic solution for injection due to lack of assurance of sterility. The recalled product consists of 2,750 single-use 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: This is an FDA Class II recall of a sterile injectable ophthalmic product. Lack of sterility assurance in intraocular injections poses significant risk of serious infection and complications, meeting the Class II severity threshold.
Plain-English summary
Edge Pharma, LLC is recalling Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe (NDC 05446-1118-01) due to lack of assurance of sterility. The product is a single-use syringe for intraocular injection manufactured by Edge Pharma, LLC, located at 856 Hercules Dr, Colchester, VT 05446.
A total of 2,750 syringes with lot code 09-2021-16@1 and expiration date 12/29/2021 have been distributed nationwide. This is a Class II recall issued by the FDA.
Consumers should not use the recalled syringes. Healthcare professionals and consumers with questions or concerns about this recall should contact Edge Pharma, LLC or consult with their healthcare provider.
The recalled product
- Product
- Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Injectable
- Affected units
- 2,750
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)
- 09-2021-16@1 12/29/2021
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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