Class II · Moderate risk
Myxredlin
CGMP Deviations
Humalog KwikPen (Insulin Lispro)
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.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
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
Affected NDC
0002-8799-59
Compare with the code on your package — it is the most precise check available.
Drug: Insulin Category: Diabetes Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Humalog KwikPen Insulin lispro NDC 00002-8799 |
100 [iU]/mL | Injection, Solution Intravenous|subcutaneous |
Eli Lilly and Company | Rx |
- 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 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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