FDA recall D-0619-2020

Product

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

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-0619-2020