FDA recall D-391-2014

G & W Laboratories Inc · Class III · drug

Product

G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

Reason for recall

Failed Content Uniformity Specifications; at the 18 month time point.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-09-30
Report date: 2014-01-08
Termination date: 2014-08-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: South Plainfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-391-2014