Recall Enforment Report D-0884-2022

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Cardinal Health Inc., originally initiated on 04-05-2022 for the product Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 The product was recalled due to temperature abuse: products were exposed to temperatures outside of the products labeled storage conditions. The product was distributed in Nm Only and the recall is currently completed.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0884-2022	04-05-2022	05-25-2022	Class II	1 box	Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80	TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions	Completed
D-0883-2022	04-05-2022	05-25-2022	Class II	1 box	Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80	TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.	Completed
D-0882-2022	04-05-2022	05-25-2022	Class I	1 box	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	TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.	Completed

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0002-1433	Trulicity	Dulaglutide	Injection, Solution	Subcutaneous	Eli Lilly And Company	Human Prescription Drug
0002-1434	Trulicity	Dulaglutide	Injection, Solution	Subcutaneous	Eli Lilly And Company	Human Prescription Drug
0002-2236	Trulicity	Dulaglutide	Injection, Solution	Subcutaneous	Eli Lilly And Company	Human Prescription Drug
0002-3182	Trulicity	Dulaglutide	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
0002-8213	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

Field Name	Field Value
Event ID	89976 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0884-2022 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	NM only 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	Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
Reason For Recall	TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1 box 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	05-25-2022
Recall Initiation Date	04-05-2022 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	Letter 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	Cardinal Health Inc.
Code Info	Lot #: D484557A, Exp: 10/25/2023. 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	0002-1433-01; 0002-1433-80; 0002-1433-61; 0002-1434-01; 0002-1434-80; 0002-1434-61; 0002-2236-01; 0002-2236-80; 0002-2236-61; 0002-3182-01; 0002-3182-80; 0002-3182-61
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.

Field Name	Field Value
Event ID	89976 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0883-2022 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	NM only 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	Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80
Reason For Recall	TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1 box 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	05-25-2022
Recall Initiation Date	04-05-2022 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	Letter 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	Cardinal Health Inc.
Code Info	Lot #: D482749A, Exp: 10/15/2023. 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.
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.

Field Name	Field Value
Event ID	89976 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0882-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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	NM only 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	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
Reason For Recall	TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1 box 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	05-25-2022
Recall Initiation Date	04-05-2022 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	Letter 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	Cardinal Health Inc.
Code Info	Unknown 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; 0002-7712-01; 0002-7712-27; 0002-7712-61; 0002-7714-01; 0002-7714-59; 0002-7714-61; 0002-8213-01; 0002-8213-05
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.