D-1440-2014 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 23, 2014
- Initiation Date
- July 3, 2014
- Termination Date
- December 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111,388 Bottles
Product Description
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.
Reason for Recall
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Distribution Pattern
Nationwide
Code Information
Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015.