Why it was recalled
cGMP deficiencies
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023
Where it was sold
Recalled product was distributed nationwide within the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0452-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 21, 2022
- FDA report date
- Feb 2, 2022
- Quantity
- 233,199/10 g aerosol containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0452-2022, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 89415
- Address
- 3711 Collins Ferry Rd
- Code information
- Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023
- Postal code
- 26505-2362
- Report date
- Feb 2, 2022
- Product type
- Drugs
- Recall number
- D-0452-2022
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc
- Product quantity
- 233,199/10 g aerosol containers
- Termination date
- Mar 12, 2024
- Reason for recall
- cGMP deficiencies
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Recalled product was distributed nationwide within the United States.
- Recall initiation date
- Jan 21, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 25, 2022