G & W Laboratories, Inc. recalls 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…

Recall date

June 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0945-2017

FDA classification

Class III

Brand / firm

G & W Laboratories, Inc.

Sold / distributed

Nationwide

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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