FDA-Drug2022-02-02Class II
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.
Mylan Pharmaceuticals Inc
Hazard
cGMP deficiencies
Sold states
Recalled product was distributed nationwide within the United States.
Affected count
233,199/10 g aerosol containers
Manufactured in
3711 Collins Ferry Rd, Morgantown, WV, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0452-2022Don't want to check this manually?
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