Drug product
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
D-0773-2021
Product summary
- Event
- Event 88505
- Status
- Terminated
- Classification
- Class II
- Quantity
- 119,539 4-packs
- Official record key
drug-enforcement:D-0773-2021
Official wording
Reason: Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Code information: Lot number: D396436C
Distribution pattern: USA Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label error