Class III
Terminated
Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
This recall has been terminated (originally issued July 23, 2014).
- Company
- Fougera Pharmaceuticals Inc.
- Recall Initiated
- July 3, 2014
- Posted
- July 23, 2014
- Recall Number
- D-1440-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 111,388 Bottles
- Firm Location
- Melville, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Distribution
Nationwide
Lot / Code Info
Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015.
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...
Mar 29, 2017 · Class II
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 Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A divi...
Mar 19, 2014 · Class III
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