Recall: D-1152-2014

Class III - Minor Violations

Class IIIClassification

2014-01-29Initiated

TerminatedStatus

Fougera Pharmaceuticals Inc.Firm

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

Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.

Distribution

Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.