FDA recall D-0945-2017

Product

G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

Reason for recall

Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-06-02

Report date

2017-07-12

Termination date

2018-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Plainfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0945-2017