Class III
Terminated
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.
This recall has been terminated (originally issued March 19, 2014).
- Company
- Fougera Pharmaceuticals Inc.
- Recall Initiated
- January 29, 2014
- Posted
- March 19, 2014
- Recall Number
- D-1152-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 493,192 tubes
- Firm Location
- Melville, NY, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
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
More recalls by Fougera Pharmaceuticals Inc.
Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Ph...
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FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gr...
Nov 19, 2014 · Class II
Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for...
Jul 23, 2014 · Class III
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