Recalls / Class I
Class ID-0882-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Humalog
- Generic name
- Insulin Lispro
- Active ingredient
- Insulin Lispro
- Route
- Intravenous, Subcutaneous
- NDCs
- 0002-7516, 0002-7510, 0002-7533, 0002-8799, 0002-7714, 0002-8213, 0002-0800, 0002-7712, 0002-8208
- FDA application
- BLA020563
- Affected lot / code info
- Unknown
Why it was recalled
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Eli Lilly and Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 1 box
- Distribution pattern
- NM only
Timeline
- Recall initiated
- 2022-04-05
- FDA classified
- 2022-05-19
- Posted by FDA
- 2022-05-25
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0882-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.