FDA recall D-0452-2022

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

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

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