Why it was recalled
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Product description
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
Lot numbers, UPCs & expiration codes
Lot #: 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15
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-1152-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 29, 2014
- FDA report date
- Mar 19, 2014
- Quantity
- 493,192 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fougera Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1152-2014, exactly as published.
Show all FDA fields
- City
- Melville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 67329
- Address
- 60 Baylis Rd
- Code information
- Lot #: 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15
- Postal code
- 11747-3838
- Report date
- Mar 19, 2014
- Product type
- Drugs
- Recall number
- D-1152-2014
- Classification
- Class III
- Recalling firm
- Fougera Pharmaceuticals Inc.
- Product quantity
- 493,192 tubes
- Termination date
- Dec 8, 2015
- Reason for recall
- Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jan 29, 2014
- Initial firm notification
- Letter
- Center classification date
- Mar 7, 2014