Reported Feb 2, 2022 · Terminated

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx…

Mylan Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Pharmaceuticals Inc · 3711 Collins Ferry Rd · Morgantown, WV · 26505-2362

Is this the product you have?

  • 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.
Lot codes and dates
    • Lot #: 32925
    • Exp. date May 2023
    • 33010
    • Exp. date June 2023
    • 33119
    • 33123
    • Exp. date August 2023
Amount recalled
233,199/10 g aerosol containers

Where it was sold

  • Nationwide

Why it was recalled

cGMP deficiencies

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 12, 2024 · Data as of Sep 19, 8:05 PM UTC

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