FDA Drug recall D-0519-2017
Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles…
- FDA Drug
- Class III
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class III recall of Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles… by G And W Laboratories, citing CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0519-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-02-28 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | G And W Laboratories |
| Distribution | US |
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.
Reason
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Identifiers
| code_info | Lot #'s: a) 032100042, 032100043, 032100044, 032100045, Exp 06/17; b) 032100038, 032100039, 032100040, 032100041, Exp 0…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0519-2017%22
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