Trulicity Injection, Solution
FDA Recall NDC 0002-2236
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Trulicity (NDC 0002-2236). A significant event, classified as Class II, was initiated on Apr 05, 2022 by Eli Lilly And Company. The reported reason for this action was: "TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Apr 05, 2022
May 25, 2022
1 box
Recall Profile & Regulatory Data
Event ID
89976
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NM only
Product Description
Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
Batch or Lot Expiration Information
Lot# : D484557A, Exp: 10/25/2023.
Affected Packages Involved in this Recall
0002-1433-01Product
0002-1433-80Product
0002-1433-61Product
0002-1434-01Product
0002-1434-80Product
0002-1434-61Product
0002-2236-01Product
0002-2236-80Product
0002-2236-61Product
0002-3182-01Product
0002-3182-80Product
0002-3182-61Product
Class II Terminated
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.
Aug 19, 2021
Sep 01, 2021
119,539 4-packs
Recall Profile & Regulatory Data
Event ID
88505
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Eli Lilly & Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Aug 07, 2023
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
Batch or Lot Expiration Information
Lot# Lot number: D396436C
Affected Packages Involved in this Recall
0002-1433-01Product
0002-1433-80Product
0002-1433-61Product
0002-1434-01Product
0002-1434-80Product
0002-1434-61Product
0002-2236-01Product
0002-2236-80Product
0002-2236-61Product
0002-3182-01Product
0002-3182-80Product
0002-3182-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
