Status
Terminated
Drug Enforcement D-391-2014
Failed Content Uniformity Specifications; at the 18 month time point.
Classification
Class III
Report Date
January 8, 2014
Termination Date
August 28, 2014
Product Information
- 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
- Product quantity
- 187,368 metal tubes
- Reason for recall
- Failed Content Uniformity Specifications; at the 18 month time point.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- G & W Laboratories Inc
- Address
-
111 Coolidge St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-391-2014
- Event ID
- 66454
- Recall initiation date
- September 30, 2013
- Center classification date
- December 27, 2013
- Code info
- 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.
- More code info
- —