Reported Jan 8, 2014 · Terminated
G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only,…
G & W Laboratories Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: G & W Laboratories Inc · 111 Coolidge St · South Plainfield, NJ · 07080-3895
Is this the product you have?
- 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 byG&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
- Lot codes and dates
15 gm Lot #: 022211002022212001- 022212008022212010-022212012022212017022213001022213005022213008 60 gm Lot #: 022211002022212001- 022212007022212009022212010022212012-022212016022212018022212019022213002
- Amount recalled
- 187,368 metal tubes
Where it was sold
- Nationwide
Why it was recalled
Failed Content Uniformity Specifications; at the 18 month time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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