On April 5, 2022, a Class II recall was initiated for Trulicity (dulaglutide) injection, 0.75 mg/0.5mL, once weekly, 4 Single-Dose Pens, NDC 0002-1433-80. The recall, identified as D-0884-2022, was initiated by Cardinal Health Inc.
The stated reason for the recall was temperature abuse, meaning the products were exposed to temperatures outside their labeled storage conditions. The manufacturer of record is Eli Lilly and Company, based in Indianapolis, IN.
This action is classified as Class II by the FDA. The recall status is listed as completed as of the available record.
No additional details regarding patient impact, distribution scope, or corrective actions were included in this event record. The classification and reason are reported here as stated by the recalling firm and regulatory filing, without implying that the product itself poses an inherent safety risk beyond the noted storage exposure issue.
Readers seeking more background on dulaglutide, its approved uses, and related regulatory history can consult the compound overview for additional context.