FDA recall D-1496-2020

Product

Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, 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 in the U.S.

Key facts

Status

Terminated

Initiation date

2020-07-20

Report date

2020-08-19

Termination date

2023-06-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1496-2020