# FDA recall D-0307-2021

> **Edge Pharma, LLC** · Class III · drug recall initiated 2020-12-22.

## Product

Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01

## Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

## Distribution

PA only

## Key facts

- **Recall number:** D-0307-2021
- **Recalling firm:** Edge Pharma, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-22
- **Report date:** 2021-03-24
- **Termination date:** 2021-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Colchester, VT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0307-2021

## Citation

> AI Analytics. FDA recall D-0307-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0307-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*