Eli Lilly & Company: Drug Recall

Recall #D-0773-2021 · 08/19/2021

Class II: Risk

Recall Details

Recall Number: D-0773-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Eli Lilly & Company
Status: Terminated
Date Initiated: 08/19/2021
Location: Indianapolis, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 119,539 4-packs

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.

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

Distribution Pattern

USA Nationwide

Other Recalls by Eli Lilly & Company

Class II: Risk 03/12/2024

CGMP Deviations
Class I: Dangerous 09/24/2021

SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II: Risk 06/29/2021

cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.

View all recalls by Eli Lilly & Company →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.