FDA-Drug2019-12-18Class III
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Glenmark Pharmaceuticals Inc., USA
Hazard
Defective delivery system; product is not foaming or is coming out as liquid.
Sold states
Nationwide
Affected count
a) 480 packs; b) 240 packs
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0619-2020Don't want to check this manually?
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