Mylan Pharmaceuticals Inc recalls Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx O
Recalled February 2, 2022 · FDA recall D-0452-2022 · Mylan Pharmaceuticals
Hazard
cGMP deficiencies · FDA Class II
Units
233,199/10 g aerosol containers
Sold at
Recalled product was distributed nationwide within the United States.
Description
cGMP deficiencies
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.
Manufacturer(s)
Mylan Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →