FDAFDA · Food and drugs·Recall number 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 Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
Published January 8, 2014 · Recall initiated: September 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Content Uniformity Specifications; at the 18 month time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- G & W Laboratories Inc
- Distributor
- Nationwide
- UPC
- 022212012022
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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