FDA 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%.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2014-01-29

Report date

2014-03-19

Termination date

2015-12-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1152-2014