Drug product
JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA
D-0468-2023
Product summary
- Event
- Event 91879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 69,375 bottles
- Official record key
drug-enforcement:D-0468-2023
Official wording
Reason: Labeling: Label Mix-up
Code information: Lot #: a) and b) E61835, exp. date JUN 2025
Distribution pattern: Product was distributed nationwide within the United States and PR
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up