PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 1, 2021 Initiated: August 19, 2021 #D-0773-2021

Product Description

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.

Details

Recalling Firm
Eli Lilly & Company
Units Affected
119,539 4-packs
Distribution
USA Nationwide
Location
Indianapolis, IN

Frequently Asked Questions

What product was recalled?
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. Recalled by Eli Lilly & Company. Units affected: 119,539 4-packs.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 1, 2021. Severity: Moderate. Recall number: D-0773-2021.