Agency classClass IIOur severity:Severe FDA (Drugs)·D-0402-2022·Announced 2022-02-02

Epinephrine/Lidocaine Ophthalmic Injection Syringe Recall for Sterility Assurance

Edge Pharma is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection due to lack of assurance of sterility. The recall affects 2,568 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: The FDA classified this recall as Class II. A sterility defect in an intraocular injection product represents a significant potential for serious harm, as contamination could cause sight-threatening intraocular infections. Although no illnesses or injuries are reported in the source text, the inherent risk of a non-sterile injectable drug intended for the eye warrants a Severe classification under the Class II criterion.

Plain-English summary

Edge Pharma, LLC is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe. The product is intended for intraocular injection and is supplied in single-use syringes.

The recall is being conducted due to lack of assurance of sterility. The affected product was distributed nationwide. A total of 2,568 syringes have been recalled under lot codes 10-2021-18@4 (dated 12/08/2021) and 11-2021-01@3 (dated 12/22/2021).

Patients or healthcare providers who have received or used this product should contact Edge Pharma, LLC or their healthcare provider for further guidance. The product should not be used.

The recalled product

Product: Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
Manufacturer: Edge Pharma, LLC
Category: Drug — Sterile Injectable - Ophthalmic
Hazard: lack-of-sterility
contamination-risk
intraocular-infection-risk
Affected units: 2,568

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)

10-2021-18@4 12/08/2021& 11-2021-01@3 12/22/2021

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.

See all 56 products in this recall →

Same manufacturer · Edge Pharma, LLC

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