Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical Recalled by Cardinal Health Inc. Due to CGMP Deviations: Intermittent exposure to temperature excursion during...

Date: March 15, 2021
Company: Cardinal Health Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cardinal Health Inc. directly.

Affected Products

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey

Quantity: 834 aerosol containers

Why Was This Recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Where Was This Sold?

This product was distributed to 3 states: FL, GA, SC

Affected (3 states)Not affected

About Cardinal Health Inc.

Cardinal Health Inc. has 240 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report