Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Compa...
FDA Recall #D-0773-2021 — Class II — August 19, 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.
Recalling Firm
Eli Lilly & Company — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
119,539 4-packs
Distribution
USA Nationwide
Code Information
Lot number: D396436C
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated