CLASS II Drug recall · Reported 2 Feb 2022 · FDA Enforcement Report
Proctofoam HC (hydrocortisone acetate recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, distributed nationwide in the US. The recall was initiated on 21 Jan 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0452-2022
- FDA event ID
- 89415
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Brand
- Proctofoam
- Manufacturer
- Viatris Specialty LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2022
- FDA classified
- 25 Jan 2022
- Reported
- 2 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 21 Jan 2022 | Recall initiated by company | |
| 25 Jan 2022 | Classified by FDA | +4 days |
| 2 Feb 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deficiencies
Product as listed by the FDA
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.
Where it was distributed
Recalled product was distributed nationwide within the United States.
Questions about this recall
Why was it recalled?
cGMP deficiencies
Which lots are affected?
Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023
Where was it sold?
Recalled product was distributed nationwide within the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Pharmaceuticals
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|---|---|---|---|---|---|
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| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Pramoxine Hydrocortisone recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Proctofoam HC (hydrocortisone acetate recalled by Cardinal HealthProctofoam | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |