Drug 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.
D-0452-2022
Product summary
- Event
- Event 89415
- Status
- Terminated
- Classification
- Class II
- Quantity
- 233,199/10 g aerosol containers
- Official record key
drug-enforcement:D-0452-2022
Official wording
Reason: cGMP deficiencies
Code information: Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023
Distribution pattern: Recalled product was distributed nationwide within the United States.
Derived failure modes
-
Manufacturing or process control
cGMP deficiencies