Glenmark Pharmaceuticals Inc., USA recalls Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manuf…

Recall date

November 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0618-2020

FDA classification

Class III

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430