Proctofoam HC — Class II drug recall D-0452-2022
Terminated recall by Mylan Pharmaceuticals Inc, reported 2022-02-02, distributed nationwide. cGMP deficiencies
| Recall number | D-0452-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc, Morgantown, WV, United States |
| Recall initiated | 2022-01-21 |
| Classified | 2022-01-25 |
| Reported by FDA | 2022-02-02 |
| Terminated | 2024-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 233,199 |
| Reason classes | cgmp |
| NDC | 00037-6822, 00037-6822-10 |
| Lot numbers | 32925, 33010, 33119, 33123 |
| Expiration dates | 2023-05-20, 2023-06-20, 2023-08-20 |
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.
Reason for recall
cGMP deficiencies
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0452-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.