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.
Reported: February 2, 2022 Initiated: January 21, 2022 #D-0452-2022
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.
Reason for Recall
cGMP deficiencies
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc
- Units Affected
- 233,199/10 g aerosol containers
- Distribution
- Recalled product was distributed nationwide within the United States.
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mylan Pharmaceuticals Inc. Units affected: 233,199/10 g aerosol containers.
Why was this product recalled? ▼
cGMP deficiencies
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 2, 2022. Severity: Moderate. Recall number: D-0452-2022.
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