D-0452-2022 Class II Terminated
FDA drug recall D-0452-2022 was initiated by Mylan Pharmaceuticals Inc on Jan 21, 2022 and is designated Class II. Reason for recall: cGMP deficiencies The recall status is terminated (terminated Mar 12, 2024). Affected quantity: 233,199/10 g aerosol containers.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 2, 2022
- Initiation Date
- Jan 21, 2022
- Termination Date
- Mar 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 233,199/10 g aerosol containers
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
Distribution pattern
Recalled product was distributed nationwide within the United States.
Code information
Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0452-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026