Edge Pharma Lidocaine HCl/Epinephrine Injection Lacks Sterility Assurance
Edge Pharma is recalling approximately 8,140 syringes of Lidocaine HCl/Epinephrine sterile buffered injection solution due to lack of assurance of sterility. The product was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. 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 pharmaceutical product. Lack of sterility assurance in a product administered by injection presents a significant risk of serious infection and adverse health consequences, meeting the threshold for a Severe rating.
Plain-English summary
Edge Pharma, LLC is recalling Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe (NDC 05446-1268-01) because the product lacks assurance of sterility.
The recalled product consists of approximately 8,140 syringes distributed nationwide. The affected lot codes are 10-2021-25@4 dated 12/08/2021 and 11-2021-08@6 dated 12/22/2021.
Consumers and healthcare providers who have received this product should stop use and contact Edge Pharma, LLC at (802) 992-1178 or 856 Hercules Dr., Colchester, VT 05446 for return instructions and further information.
The recalled product
- Product
- Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
- Manufacturer
- Edge Pharma, LLC
- Affected units
- 8,140
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)
- 10-2021-25@4 12/08/2021 11-2021-08@6 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.
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