Recalls / Class II
Class IID-0452-2022
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.
- Brand name
- Proctofoam
- Generic name
- Pramoxine Hydrochloride Hydrocortisone Acetate
- Active ingredients
- Hydrocortisone Acetate, Pramoxine Hydrochloride
- Route
- Topical
- NDC
- 0037-6822
- FDA application
- ANDA086195
- Affected lot / code info
- Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023
Why it was recalled
cGMP deficiencies
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc
- Manufacturer
- Viatris Specialty LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3711 Collins Ferry Rd, Morgantown, West Virginia 26505-2362
Distribution
- Quantity
- 233,199/10 g aerosol containers
- Distribution pattern
- Recalled product was distributed nationwide within the United States.
Timeline
- Recall initiated
- 2022-01-21
- FDA classified
- 2022-01-25
- Posted by FDA
- 2022-02-02
- Terminated
- 2024-03-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0452-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.