Drug Recall Enforcement Report Class II voluntary initiated by Eli Lilly & Company, originally initiated on 03-12-2024 for the product 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 The product was recalled due to cgmp deviations. The product was distributed nationwide and the recall is currently completed.
Field Name |
Field Value |
Event ID |
94214 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number |
D-0445-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification |
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern |
Nationwide USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
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 |
Reason For Recall |
CGMP Deviations What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity |
700 vials Product Quantity The amount of product subject to recall. |
Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date |
04-24-2024 |
Recall Initiation Date |
03-12-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Initial Firm Notification |
E-Mail Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type |
Drugs |
Recalling Firm |
Eli Lilly & Company |
Code Info |
Batch number: D608951C, exp 4/10/2025 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Recalled NDC Packages |
0002-7510-01; 0002-7510-17; 0002-7510-99; 0002-7533-01; 0002-8799-01; 0002-8799-59; 0002-8799-61; 0002-7516-01; 0002-7516-59; 0002-7516-99; 0002-7714-01; 0002-7714-59; 0002-7714-61; 0002-8213-01; 0002-8213-05; 0002-0800-01; 0002-7712-01; 0002-7712-27; 0002-7712-61; 0002-8208-01; 0002-8208-27 |
Status |
Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections. |
Recalled Products
NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
0002-0800 | | Diluent | Injection, Solution | | Eli Lilly And Company | Drug For Further Processing |
0002-0800 | Sterile Diluent | Diluent | Injection, Solution | Subcutaneous | Eli Lilly And Company | Human Prescription Drug |
0002-7510 | Humalog | Insulin Lispro | Injection, Solution | Intravenous; Subcutaneous | Eli Lilly And Company | Human Prescription Drug |
0002-7516 | Humalog | Insulin Lispro | Injection, Solution | Intravenous; Subcutaneous | Eli Lilly And Company | Human Prescription Drug |
0002-7533 | Humalog | Insulin Lispro | Injection, Solution | Intravenous; Subcutaneous | Eli Lilly And Company | Human Prescription Drug |
0002-7712 | Humalog KwikPen | Insulin Lispro | Injection, Solution | Subcutaneous | Eli Lilly And Company | Human Prescription Drug |
0002-7714 | Humalog Junior KwikPen | Insulin Lispro | Injection, Solution | Subcutaneous | Eli Lilly And Company | Human Prescription Drug |
0002-8208 | Humalog Tempo Pen | Insulin Lispro | Injection, Solution | Subcutaneous | Eli Lilly And Company | Human Prescription Drug |
0002-8213 | Humalog Tempo Pen | Insulin Lispro | Injection, Solution | Subcutaneous | Eli Lilly And Company | Human Prescription Drug |
0002-8799 | Humalog KwikPen | Insulin Lispro | Injection, Solution | Intravenous; Subcutaneous | Eli Lilly And Company | Human Prescription Drug |