Class III
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, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
This recall has been terminated (originally issued January 8, 2014).
- Company
- G & W Laboratories Inc
- Recall Initiated
- September 30, 2013
- Posted
- January 8, 2014
- Recall Number
- D-391-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 187,368 metal tubes
- Firm Location
- South Plainfield, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Content Uniformity Specifications; at the 18 month time point.
Distribution
Nationwide
Lot / 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.
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