Home / Recalls / AbbVie Inc / D-1289-2014

D-1289-2014 Class II Terminated

Recalled by AbbVie Inc — North Chicago, IL

Recall Details

Product Type
Drugs
Report Date
May 7, 2014
Initiation Date
March 10, 2014
Termination Date
June 22, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 kits

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.

Reason for Recall

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #:1013566, Exp 12/08/16

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