FDA recall D-1660-2012

Product

Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,

Reason for recall

Subpotent; fluocinolone acetonide.

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2012-08-15

Report date

2012-09-05

Termination date

2013-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1660-2012