FDA Drug December 18, 2019 Class III — Least Serious

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

Hazard

Defective delivery system; product is not foaming or is coming out as liquid.

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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,

Brand: Glenmark Pharmaceuticals Inc., USA
UPC: Lot 14190067, exp Jul-2021

Units Affected

a) 480 packs; b) 240 packs

Hazard

Products

Units Affected

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