FDA Recall D-0882-2022
Cardinal Health Inc. · Dublin, OH
Class I — life-threatening Completed 1500 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Recall record
- Recall number
D-0882-2022- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- NM only
- Recall initiated
- 2022-04-05
- Classified by FDA Center
- 2022-05-19
- FDA published
- 2022-05-25
- Recalling firm
- Cardinal Health Inc.
- Firm location
- Dublin, OH
Drug identification
- Brand name(s)
- HUMALOG
- Generic name(s)
- INSULIN LISPRO
- Manufacturer(s)
- Eli Lilly and Company
- NDC(s)
0002-7516, 0002-7510, 0002-7533, 0002-8799, 0002-7714, 0002-8213, 0002-0800, 0002-7712, 0002-8208- Route(s)
- INTRAVENOUS, SUBCUTANEOUS