Drug recall D-1291-2014

Class II Terminated reported May 7, 2014

Product

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.

Reason for recall

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

Lots and codes

Lot #: 1012381, 1012383, Exp 08/22/16

Recall details

Recalling firm
AbbVie Inc, North Chicago, IL
Quantity
2915 kits
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
March 10, 2014
Terminated
June 22, 2016

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