Drug recall D-1152-2014
Product
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.
Reason for recall
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Lots and 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
Recall details
- Recalling firm
- Fougera Pharmaceuticals Inc., Melville, NY
- Quantity
- 493,192 tubes
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 29, 2014
- Terminated
- December 8, 2015
Related products
- Triamcinolone Acetonide – drug information
- NDC 0168-0003 Triamcinolone acetonide · Triamcinolone Acetonide .25 mg/g · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- NDC 0168-0002 Triamcinolone acetonide · Triamcinolone Acetonide 5 mg/g · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- NDC 0168-0004 Triamcinolone acetonide · Triamcinolone Acetonide 1 mg/g · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC