# FDA recall D-0446-2022

> **Edge Pharma, LLC** · Class II · drug recall initiated 2021-12-06.

## Product

Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01

## Reason for recall

CGMP Deviations

## Distribution

nationwide

## Key facts

- **Recall number:** D-0446-2022
- **Recalling firm:** Edge Pharma, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-12-06
- **Report date:** 2022-02-02
- **Termination date:** 2023-06-07

- **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-0446-2022

## Citation

> AI Analytics. FDA recall D-0446-2022. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0446-2022. Source: US FDA. Licensed CC0.

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