FDA recall D-0773-2021

Eli Lilly & Company · Class II · 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

Reason for recall

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.

Distribution

USA Nationwide

Key facts

Status
Terminated
Initiation date
2021-08-19
Report date
2021-09-01
Termination date
2023-08-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0773-2021