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Recall Observatory FDA recall evidence

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

January 29, 2014

Class III

Product summary

Firm
Fougera Pharmaceuticals Inc.
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

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error