Drug product
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.
D-1440-2014
Product summary
- Event
- Event 68683
- Status
- Terminated
- Classification
- Class III
- Quantity
- 111,388 Bottles
- Official record key
drug-enforcement:D-1440-2014
Official wording
Reason: Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
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.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
may not meet specification