FDAFDA · Food and drugs·Recall number D-0452-2022
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.
Published February 2, 2022 · Recall initiated: January 21, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deficiencies
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PROCTOFOAM
- Manufacturer
- Mylan Pharmaceuticals Inc
- Distributor
- Recalled product was distributed nationwide within the United States.
- Lot
- Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.