FDAFDA · Food and drugs·Recall number D-1440-2014
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.
Published July 23, 2014 · Recall initiated: July 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fougera Pharmaceuticals Inc.
- Distributor
- Nationwide
- Lot
- Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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