Why it was recalled
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0519-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 28, 2017
- FDA report date
- Mar 22, 2017
- Quantity
- 39,816 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- G & W Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0519-2017, exactly as published.
Show all FDA fields
- City
- South Plainfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76641
- Address
- 111 Coolidge St
- 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.
- Postal code
- 07080-3895
- Report date
- Mar 22, 2017
- Product type
- Drugs
- Recall number
- D-0519-2017
- Classification
- Class III
- Recalling firm
- G & W Laboratories, Inc.
- Product quantity
- 39,816 bottles
- Termination date
- Dec 27, 2017
- Reason for recall
- CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 28, 2017
- Initial firm notification
- Center classification date
- Mar 14, 2017