Recalls / Class II
Class IID-0884-2022
Product
Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
- Brand name
- Trulicity
- Generic name
- Dulaglutide
- Active ingredient
- Dulaglutide
- Route
- Subcutaneous
- NDCs
- 0002-3182, 0002-1433, 0002-1434, 0002-2236
- FDA application
- BLA125469
- Affected lot / code info
- Lot #: D484557A, Exp: 10/25/2023.
Why it was recalled
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Eli Lilly and Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 1 box
- Distribution pattern
- NM only
Timeline
- Recall initiated
- 2022-04-05
- FDA classified
- 2022-05-19
- Posted by FDA
- 2022-05-25
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0884-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.