Why it was recalled
Failed Content Uniformity Specifications; at the 18 month time point.
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-391-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 30, 2013
- FDA report date
- Jan 8, 2014
- Quantity
- 187,368 metal tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- G & W Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-391-2014, exactly as published.
Show all FDA fields
- City
- South Plainfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66454
- Address
- 111 Coolidge St
- 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.
- Postal code
- 07080-3895
- Report date
- Jan 8, 2014
- Product type
- Drugs
- Recall number
- D-391-2014
- Classification
- Class III
- Recalling firm
- G & W Laboratories Inc
- Product quantity
- 187,368 metal tubes
- Termination date
- Aug 28, 2014
- Reason for recall
- Failed Content Uniformity Specifications; at the 18 month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 30, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 27, 2013