Topical Anesthetic/Corticosteroid Recalled

Mylan Pharmaceuticals Inc is voluntarily recalling 233,199 containers of Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol foam. The February 2, 2022, US Food and Drug Administration (FDA) Enforcement Report, which announced the recall, cited deficiencies related to Current Good Manufacturing Practice regulations but provided no details.

The recall affects Proctofoam HC in 10-g aerosol containers (NDC 0037-6822-10) from lots 32925 (Exp. 5/23), 33010 (Exp. 6/23), 33119 (Exp. 8/23), and 33123 (Exp. 8/23). The product was distributed by Meda Pharmaceuticals, Somerset, NJ, throughout the United States.

Mylan Pharmaceuticals initiated the recall January 21, 2022. The FDA designated the recall Class II on January 25, 2022, signaling use of the affected product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Proctofoam HC is a prescription topical anesthetic indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.