Recalls / Class III
Class IIID-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.
- Affected 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.
Why it was recalled
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Recalling firm
- Firm
- G & W Laboratories, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 111 Coolidge St, N/A, South Plainfield, New Jersey 07080-3895
Distribution
- Quantity
- 39,816 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2017-02-28
- FDA classified
- 2017-03-14
- Posted by FDA
- 2017-03-22
- Terminated
- 2017-12-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0519-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.