# FDA recall D-0478-2024

> **Imprimis NJOF, LLC** · Class III · drug recall initiated 2024-04-10.

## 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

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0478-2024
- **Recalling firm:** Imprimis NJOF, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-04-10
- **Report date:** 2024-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ledgewood, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0478-2024

## Citation

> AI Analytics. FDA recall D-0478-2024. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0478-2024. Source: US FDA. Licensed CC0.

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