Recalls / Class II
Class IID-0773-2021
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
- 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 number: D396436C
Why it was recalled
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.
Recalling firm
- Firm
- Eli Lilly & Company
- Manufacturer
- Eli Lilly and Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 839 S Delaware St, N/A, Indianapolis, Indiana 46225-1782
Distribution
- Quantity
- 119,539 4-packs
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2021-08-19
- FDA classified
- 2021-08-26
- Posted by FDA
- 2021-09-01
- Terminated
- 2023-08-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0773-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.