Clindamycin Phosphate Topical Solution USP recalled over manufacturing violations

Recall date

February 28, 2017

Source

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

Official notice title

G & W Laboratories, Inc. recalls Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL…

Recall number

D-0519-2017

FDA classification

Class III

Brand / firm

G & W Laboratories, Inc.

Sold / distributed

Nationwide in the USA.

Why it was recalled

CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.

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

What was recalled

Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092.