Lupron Depot-ped Kit
FDA Recall NDC 0074-2108
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lupron Depot-ped (NDC 0074-2108). 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
12 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-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 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 0074-3779-03, UPC 3 00743 77903 5.
Batch or Lot Expiration Information
Lot# :1013566, Exp 12/08/16
Affected Packages Involved in this Recall
0074-2108-03Product
0074-2282-03Product
0074-2440-03Product
0074-3779-03Product
0074-9694-03Product
0074-3575-01Product
0074-3410-01Product
0074-0010-01Product
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.
