Class II · Moderate risk Completed
Sterile Diluent
Reason CGMP Deviations
Humalog KwikPen
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
What was recalled
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
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 0002-8799-59
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0882-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Insulin recalls
See all
Class II · Moderate risk Ongoing
Admelog
Reason Lack of Assurance of Sterility: Malformed crimped collar seal
Class I · High risk Terminated
Insulin Glargine
Reason Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk Terminated
Insulin Glargine
Reason Labeling: Missing label on the vial
Class I · High risk Terminated
Semglee
Reason Labeling: Missing Label: label missing from some Semglee prefilled pens.
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