On April 5, 2022, a Class I recall was initiated for Humalog KwikPen, an insulin lispro injection product. The recall was classified as Class I by the FDA.
The product involved is Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, packaged 5x3 mL prefilled pens per box. It was marketed by Lilly USA, LLC of Indianapolis, IN, under Box NDC 0002-8799-59 and Pen NDC 002-7516-59.
The stated reason for the recall was temperature abuse. The products were exposed to temperatures outside their labeled storage conditions due to inclement weather. Cardinal Health Inc. is listed as the recalling firm.
The recall status is listed as completed. This event carries the identifier D-0882-2022 in FDA recall records.
This brief reports only the facts provided in the recall record, including the classification, reason, firm, and initiation date. No additional claims about product safety or harm are made beyond what is stated in the recall documentation.
Readers seeking more background on insulin lispro can consult the compound overview for additional context.