Lupron Depot Kit
FDA Recall NDC 0074-3473
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Lupron Depot (NDC 0074-3473). A significant event, classified as Class II, was initiated on Mar 10, 2014 by Abbvie Inc.. The reported reason for this action was: "Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Mar 10, 2014
May 07, 2014
7362 kits
Recall Profile & Regulatory Data
Event ID
67709
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AbbVie Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 22, 2016
Product Description
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3 00743 34603 9.
Batch or Lot Expiration Information
Lot# : 1014204, Exp 10/11/15; 1014485, Exp 12/11/16; and 1015007, Exp 12/06/16
Affected Packages Involved in this Recall
0074-3473-03Product
0074-3683-03Product
0074-3642-03Product
0074-3346-03Product
Class II Terminated
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Mar 10, 2014
May 07, 2014
36 kits
Recall Profile & Regulatory Data
Event ID
67709
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AbbVie Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 22, 2016
Product Description
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3473-03, UPC 3 00743 47303 2.
Batch or Lot Expiration Information
Lot# 1013976, Exp 09/25/15
Affected Packages Involved in this Recall
0074-3473-03Product
0074-3683-03Product
0074-3642-03Product
0074-3346-03Product
Class II Terminated
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Mar 10, 2014
May 07, 2014
2915 kits
Recall Profile & Regulatory Data
Event ID
67709
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AbbVie Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 22, 2016
Product Description
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3642-03, UPC 3 00743 64203 2.
Batch or Lot Expiration Information
Lot# : 1012381, 1012383, Exp 08/22/16
Affected Packages Involved in this Recall
0074-3473-03Product
0074-3683-03Product
0074-3642-03Product
0074-3346-03Product
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.
