Recalls / Class II
Class IID-0529-2021
Product
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey
- Brand name
- Proctofoam
- Generic name
- Pramoxine Hydrochloride Hydrocortisone Acetate
- Active ingredients
- Hydrocortisone Acetate, Pramoxine Hydrochloride
- Route
- Topical
- NDC
- 0037-6822
- FDA application
- ANDA086195
- Affected lot / code info
- 33119
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Viatris Specialty LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 834 aerosol containers
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0529-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.