FDA recall D-0519-2017

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2017-02-28

Report date

2017-03-22

Termination date

2017-12-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Plainfield, NJ, United States

Primary source

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