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.

Recall Number: D-1152-2014

Firm: Fougera Pharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20140319

Initiation Date: 20140129

Termination Date: 20151208

Reason for Recall

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.