Drug 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.
D-1152-2014
Product summary
- Event
- Event 67329
- Status
- Terminated
- Classification
- Class III
- Quantity
- 493,192 tubes
- Official record key
drug-enforcement:D-1152-2014
Official wording
Reason: Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
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
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Label Error