Reported Mar 22, 2017 · Terminated
Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL…
G & W Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: G & W Laboratories, Inc. · 111 Coolidge St · South Plainfield, NJ · 07080-3895
Is this the product you have?
- 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 byG&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080
- Distributed byActavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092
- Lot codes and dates
Lot #'s: a) 032100042032100043032100044032100045Exp 06/17b) 032100038032100039032100040032100041Exp 05/17032100046032100047032100048032100049Exp 06/17
- Amount recalled
- 39,816 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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