# FDA recall D-0452-2022

> **Mylan Pharmaceuticals Inc** · Class II · drug recall initiated 2022-01-21.

## Product

Proctofoam HC (hydrocortisone acetate 1% and  pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120,   NDC 0037-6822-10.

## Reason for recall

cGMP deficiencies

## Distribution

Recalled product was distributed nationwide within the United States.

## Key facts

- **Recall number:** D-0452-2022
- **Recalling firm:** Mylan Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-21
- **Report date:** 2022-02-02
- **Termination date:** 2024-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0452-2022

## Citation

> AI Analytics. FDA recall D-0452-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0452-2022. Source: US FDA. Licensed CC0.

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