FDA recall D-1289-2014

Product

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

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-03-10

Report date

2014-05-07

Termination date

2016-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1289-2014