FDA Drug recall D-391-2014
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 Lab…
- FDA Drug
- Class III
- terminated
- Published 2014-01-08
On 2014-01-08 the FDA classified a Class III recall of 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 Lab… by G And W Laboratories, citing failed Content Uniformity Specifications; at the 18 month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-391-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-09-30 |
| Published | 2014-01-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | G And W Laboratories |
| Distribution | US |
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
Failed Content Uniformity Specifications; at the 18 month time point.
Identifiers
| ndc | 0713-0222-15 |
|---|---|
| ndc | 0713-0222-60 |
| ndc | 0713-0223-15 |
| ndc | 0713-0223-60 |
| ndc | 0713-0224-15 |
| ndc | 0713-0224-60 |
| code_info | 15 gm Lot #: 022211002, 022212001- 022212008, 022212010-022212012, 022212017, 022213001, 022213005, 022213008 60 gm L…15 gm Lot #: 022211002, 022212001- 022212008, 022212010-022212012, 022212017, 022213001, 022213005, 022213008 60 gm Lot #: 022211002, 022212001- 022212007, 022212009, 022212010, 022212012-022212016, 022212018, 022212019, 022213002. |
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-391-2014%22
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