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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- G & W Laboratories, Inc.
- Reason for Recall:
- CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0519-2017
Related Recalls
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.