FDA recall D-1497-2020

Product

Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.

Reason for recall

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-07-24

Report date

2020-08-19

Termination date

2020-12-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1497-2020