Humalog Injection, Solution
FDA Recall NDC 0002-8213
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Humalog (NDC 0002-8213). A significant event, classified as Class II, was initiated on Mar 12, 2024 by Eli Lilly And Company. The reported reason for this action was: "CGMP Deviations"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
CGMP Deviations
Mar 12, 2024
Apr 24, 2024
700 vials
Recall Profile & Regulatory Data
Event ID
94214
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Eli Lilly & Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Product Description
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01
Batch or Lot Expiration Information
Batch# Batch number: D608951C, exp 4/10/2025
Affected Packages Involved in this Recall
0002-7510-01Product
0002-7510-17Product
0002-7510-99Product
0002-7533-01Product
0002-8799-01Product
0002-8799-59Product
0002-8799-61Product
0002-7516-01Product
0002-7516-59Product
0002-7516-99Product
0002-7714-01Product
0002-7714-59Product
0002-7714-61Product
0002-8213-01Product
0002-8213-05Product
0002-0800-01Product
0002-7712-01Product
0002-7712-27Product
0002-7712-61Product
0002-8208-01Product
0002-8208-27Product
Class I Completed
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Apr 05, 2022
May 25, 2022
1 box
Recall Profile & Regulatory Data
Event ID
89976
Classification
Class I
Enforcement Status
Completed
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NM only
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
Batch or Lot Expiration Information
Lot# Unknown
Affected Packages Involved in this Recall
0002-7510-01Product
0002-7510-17Product
0002-7510-99Product
0002-7533-01Product
0002-8799-01Product
0002-8799-59Product
0002-8799-61Product
0002-7516-01Product
0002-7516-59Product
0002-7516-99Product
0002-7714-01Product
0002-7714-59Product
0002-7714-61Product
0002-8213-01Product
0002-8213-05Product
0002-0800-01Product
0002-7712-01Product
0002-7712-27Product
0002-7712-61Product
0002-8208-01Product
0002-8208-27Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
