Potential health hazard — 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 Mylan Pharmaceuticals Inc Due to cGMP deficiencies
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 Mylan Pharmaceuticals Inc directly.
Affected 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.
Quantity: 233,199/10 g aerosol containers
Why Was This Recalled?
cGMP deficiencies
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Pharmaceuticals Inc
Mylan Pharmaceuticals Inc has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report