Drug recall
G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60), Rx…
FDA recall event 66454 · Class III · G & W Laboratories Inc
Key facts
| Event ID | 66454 |
|---|---|
| Recall numbers | D-391-2014 |
| Recalling firm | G & W Laboratories Inc |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Content Uniformity Specifications; at the 18 month time point. |
| Initiation date | Sep 30, 2013 |
| Report date | Jan 8, 2014 |
| Termination date | Aug 28, 2014 |
| City | South Plainfield |
| State | NJ |
| Country | United States |
| FEI number | 2210277 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: