D-391-2014 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 8, 2014
- Initiation Date
- September 30, 2013
- Termination Date
- August 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 187,368 metal tubes
Product Description
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.
Distribution Pattern
Nationwide
Code Information
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.