FDA-Drug2017-03-22Class III

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.

G & W Laboratories, Inc.
Hazard

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

Sold states
Nationwide in the USA.
Affected count
39,816 bottles
Manufactured in
111 Coolidge St, N/A, South Plainfield, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2017

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