D-0519-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 22, 2017
- Initiation Date
- February 28, 2017
- Termination Date
- December 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39,816 bottles
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #'s: a) 032100042, 032100043, 032100044, 032100045, Exp 06/17; b) 032100038, 032100039, 032100040, 032100041, Exp 05/17; 032100046, 032100047, 032100048, 032100049, Exp 06/17.