Data Foundry

Drug recalls 2024

Epinephrine-Lidocaine HCl 0 — Class III drug recall D-0478-2024

Ongoing recall by Imprimis NJOF, LLC, reported 2024-05-08, distributed nationwide. Out of specification for assay

Recall numberD-0478-2024
Product typeDrug
ClassificationClass III
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmImprimis NJOF, LLC, Ledgewood, NJ, United States
Recall initiated2024-04-10
Classified2024-04-30
Reported by FDA2024-05-08
DistributedNationwide (US)
Quantity15,414 units
Reason classespotency, specification failure
NDC71384-0640-01
Lot numbers23AUG053, 23JUL028
Expiration dates2024-08-01, 2024-08-30

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

Reason for recall

Out of specification for assay

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0478-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.