Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free recall
FDA recall D-0478-2024 · initiated Apr 10, 2024
Imprimis NJOF, LLC recalled Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free in Apr 2024 — an FDA Class III recall (D-0478-2024) because Out of specification for assay.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Out of specification for assay
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 15,414 units
Details
- 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
- Recalling company
- Imprimis NJOF, LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Apr 10, 2024
- FDA report date
- May 8, 2024
Frequently asked
- Was Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free recalled?
- Imprimis NJOF, LLC recalled Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free in Apr 2024 — an FDA Class III recall (D-0478-2024) because Out of specification for assay. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free recalled?
- Per the FDA enforcement record, the reason for recall D-0478-2024 was: Out of specification for assay
- Is a recalled Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0478-2024.