G & W Fluocinolone Acetonide Cream USP 0 — Class III drug recall D-391-2014
Terminated recall by G & W Laboratories Inc, reported 2014-01-08, distributed nationwide. Failed Content Uniformity Specifications; at the 18 month time point.
| Recall number | D-391-2014 |
|---|---|
| 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 | 2013-09-30 |
| Classified | 2013-12-27 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2014-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 187,368 metal |
| NDC | 00713-0222, 00713-0222-15, 00713-0222-60, 00713-0223, 00713-0223-15, 00713-0223-60, 00713-0224, 00713-0224-15, 00713-0224-60 |
| Lot numbers | 022211002, 022212001, 022212007, 022212008, 022212009, 022212010, 022212010-022212012, 022212012-022212016, 022212017, 022212018, 022212019, 022213001, 022213002, 022213005, 022213008 |
Product
G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
Reason for recall
Failed Content Uniformity Specifications; at the 18 month time point.
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-391-2014. 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.