Drug product
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
D-0333-2015
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 70041
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,937 bottles
- Official record key
drug-enforcement:D-0333-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Code information: Lots 1413900, 1417200, 1417300, Exp. 02/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification