FDA Drug Low Class III Terminated

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.

Reported: March 22, 2017 Initiated: February 28, 2017 #D-0519-2017

Product Description

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.

Details

Recalling Firm: G & W Laboratories, Inc.
Units Affected: 39,816 bottles
Distribution: Nationwide in the USA.
Location: South Plainfield, NJ

Frequently Asked Questions

What product 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.. Recalled by G & W Laboratories, Inc.. Units affected: 39,816 bottles.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on March 22, 2017. Severity: Low. Recall number: D-0519-2017.

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