Recalls / Class III
Class IIID-391-2014
Product
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
- Brand name
- Fluocinolone Acetonide
- Generic name
- Fluocinolone Acetonide
- Active ingredient
- Fluocinolone Acetonide
- Route
- Topical
- NDCs
- 0713-0223, 0713-0222, 0713-0224
- FDA application
- ANDA089526
- Affected 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.
Why it was recalled
Failed Content Uniformity Specifications; at the 18 month time point.
Recalling firm
- Firm
- G & W Laboratories Inc
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 Coolidge St, South Plainfield, New Jersey 07080-3895
Distribution
- Quantity
- 187,368 metal tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-09-30
- FDA classified
- 2013-12-27
- Posted by FDA
- 2014-01-08
- Terminated
- 2014-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-391-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.