Agency classClass IIOur severity:Severe FDA (Drugs)·D-0424-2022·Announced 2022-02-02

Vancomycin HCl Ophthalmic Solution Recalled for Sterility Assurance

Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was 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 pharmaceutical product for intraocular injection. Non-sterile injectable drugs intended for direct administration into the eye pose significant risk of serious infection, blindness, and other serious injury, even without reported illnesses in this notice. FDA Class II recalls of sterile drug products are classified as Severe per the rubric.

Plain-English summary

Edge Pharma LLC is recalling Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe in single-use syringes for intraocular injection. The recall is due to lack of assurance of sterility.

The product was distributed nationwide. A total of 3,360 syringes are affected. The product is intended for injection into the eye and is manufactured by Edge Pharma LLC, located at 856 Hercules Dr., Colchester, VT, 05446.

Patients who have received this product or healthcare providers who have dispensed it should take appropriate action. Consumers with questions should contact their healthcare provider or pharmacist regarding the use of this product.

The recalled product

Product: Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01
Manufacturer: Edge Pharma, LLC
Category: Drug — Injectable / Ophthalmic
Hazard: lack-of-sterility
infection-risk
contamination
Affected units: 3,360

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)

08-2021-31@2 12/12/2021 & 09-2021-20@4 01/02/2022

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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Same hazard · lack of sterility