Reported Mar 19, 2014 · Terminated
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera…
Fougera Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fougera Pharmaceuticals Inc. · 60 Baylis Rd · Melville, NY · 11747-3838
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: 485P486P487P488PExp 06/15638P639P640PExp 07/15753P754P755PExp 08/15898P756P757P758P899P900P901P902PExp 09/15
- Amount recalled
- 493,192 tubes
Where it was sold
- Nationwide
Why it was recalled
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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