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Class I: serious health riskCompleted

Cardinal Health Humalog KwikPen Recall

Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pe…

Cardinal Health Inc. · Dublin, OH

Risk level
Class I
Reported by FDA
May 25, 2022
Recall ID
D-0882-2022
Check your lot numberHow we source this data

Summary

Cardinal Health recalled Humalog KwikPen starting Apr 5, 2022. The FDA classified it as Class I (serious health risk) and published enforcement report D-0882-2022 on May 25, 2022. Reason: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. Status: Completed.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Unknown

Where it was sold

NM only

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0882-2022
Classification
Class I
Status
Completed
Recall initiated
Apr 5, 2022
FDA report date
May 25, 2022
Quantity
1 box
Recall type
Voluntary: Firm initiated
Recalling firm
Cardinal Health Inc.

Original FDA data

Every field from FDA enforcement report D-0882-2022, exactly as published.

Show all FDA fields
City
Dublin
State
OH
Status
Completed
Country
United States
Event ID
89976
Address
7000 Cardinal Pl
Code information
Unknown
Postal code
43017-1091
Report date
May 25, 2022
Product type
Drugs
Recall number
D-0882-2022
Classification
Class I
Recalling firm
Cardinal Health Inc.
Product quantity
1 box
Reason for recall
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
NM only
Recall initiation date
Apr 5, 2022
Initial firm notification
Letter
Center classification date
May 19, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0882-2022, published May 25, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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