FDA recall D-0618-2020

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-11-15

Report date

2019-12-18

Termination date

2024-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0618-2020