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Recall Observatory FDA recall evidence

Drug product

Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59

D-0882-2022

April 05, 2022

Class I

Product summary

Firm
Cardinal Health Inc.
Event
Event 89976
Status
Completed
Classification
Class I
Quantity
1 box
Official record key
drug-enforcement:D-0882-2022

Official wording

Reason: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

Code information: Unknown

Distribution pattern: NM only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.