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.
This recall has been terminated (originally issued March 22, 2017).
- Company
- G & W Laboratories Inc
- Recall Initiated
- February 28, 2017
- Posted
- March 22, 2017
- Recall Number
- D-0519-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 39,816 bottles
- Firm Location
- South Plainfield, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Distribution
Nationwide in the USA.
Lot / Code Info
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.
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