Lidocaine HCL / Bupivacaine HCL Sterile Ophthalmic Solution Lacks Sterility Assurance
Edge Pharma is recalling a sterile ophthalmic injectable solution because the manufacturer cannot guarantee that the product remains sterile. The recall affects approximately 1,202 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 solution where loss of sterility assurance creates a direct risk of serious infection. While no specific hospitalizations or illnesses are reported in the source text, the Class II classification and the critical nature of sterility for injectable solutions used near the eye warrant a Severe rating.
Plain-English summary
Edge Pharma, LLC is recalling Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (Preservative Free), 2%/0.375%, 8 mL per syringe, NDC 05446-1548-18. The recall involves approximately 1,202 syringes distributed nationwide.
The product is being recalled due to lack of assurance of sterility. Injectable ophthalmic solutions must maintain strict sterility standards to prevent serious infection when administered directly to the eye.
Consumers and healthcare providers should not use the affected product. If you have received or currently possess this product, contact Edge Pharma, LLC at 856 Hercules Dr., Colchester, VT 05446, or contact your pharmacy or healthcare provider for further instructions regarding safe return or disposal of the product.
The recalled product
- Product
- Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18
- Manufacturer
- Edge Pharma, LLC
- Affected units
- 1,202
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)
- 10-2021-26@3 12/04/2021 11-2021-09@1 12/23/2021
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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