Clindamycin Phosphate Topical Solution USP — Class III drug recall D-0519-2017
Terminated recall by G & W Laboratories, Inc., reported 2017-03-22, distributed nationwide. CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
| Recall number | D-0519-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | G & W Laboratories, Inc., South Plainfield, NJ, United States |
| Recall initiated | 2017-02-28 |
| Classified | 2017-03-14 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2017-12-27 |
| Distributed | Nationwide (US) |
| Quantity | 39,816 bottles |
| Reason classes | cgmp |
| NDC | 00472-0987-91, 00472-0987-92 |
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 for recall
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0519-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.