Drug recall D-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
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
33119
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 834 aerosol containers
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Proctofoam – drug information
- NDC 0037-6822 Proctofoam Hc · Pramoxine Hydrochloride 100 mg/10g; Hydrocortisone Acetate… · Viatris Specialty LLC