Pramoxine Hydrocortisone recalls
The FDA has published 2 recalls involving Pramoxine Hydrocortisone since 2021. The latest was reported on 2 Feb 2022. Most were for manufacturing (cgmp) deviations. Mylan Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls2since 2021
Last 12 months0reported
Class I00% of total
Ongoing0latest 2 Feb 2022
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why pramoxine hydrocortisone is recalled
Companies
By year
All pramoxine hydrocortisone recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Proctofoam HC (hydrocortisone acetate recalled by Mylan PharmaceuticalsProctofoam | Mylan Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Proctofoam HC (hydrocortisone acetate recalled by Cardinal HealthProctofoam | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
Should you stop taking Pramoxine Hydrocortisone?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.