FDA-Drug2021-06-02Class II
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
Cardinal Health Inc.
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Sold states
FL, GA, SC
Affected count
834 aerosol containers
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0529-2021Don't want to check this manually?
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