Injectable epinephrine-lidocaine recalled for failing potency specification
Imprimis NJOF, LLC is recalling epinephrine-lidocaine injectables nationwide because they failed to meet potency specifications. Patients should contact their healthcare provider regarding affected lots.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III drug recall for out-of-specification assay (potency failure). No illnesses, injuries, or deaths have been reported. The hazard is reduced medication efficacy rather than direct contamination or known adverse events.
Plain-English summary
Imprimis NJOF, LLC is recalling specific lots of epinephrine-lidocaine HCl 0.25 mg/mL and 7.5 mg/mL preservative-free single-use vials because they failed to meet assay specifications. The affected lots are 23JUL028 (expiring 8/1/2024) and 23AUG053 (expiring 8/30/2024), representing 15,414 units distributed nationwide.
When a drug is out of specification for assay, it means the measured potency does not match FDA-established standards. This could result in the medication being less effective than intended. Patients who received injections from these lots should consult their healthcare provider to discuss any medical concerns.
The FDA classifies this as a Class III recall. Healthcare providers and patients should discontinue use of product bearing these lot numbers immediately.
The recalled product
- Product
- Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Injectable / Anesthetic
- Affected units
- 15,414
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 (4)
- Lot #: 23JUL028
- Exp. Date 8/1/2024
- 23AUG053
- Exp. Date 8/30/2024
Distribution
Distributed nationwide across the United States.
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