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 #: 32925Exp. date May 202333010Exp. date June 20233311933123Exp. 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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