Drug product
Triamcinolone Acetonide Lotion USP, 0.025%, 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 0168-0336-60.
D-1441-2014
Product summary
- Event
- Event 68683
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,594 Bottles
- Official record key
drug-enforcement:D-1441-2014
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: 849R, Exp 04/2015
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
may not meet specification