FDA-Drug2014-05-07Class II

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.

AbbVie Inc
Hazard

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

Sold states
Nationwide and Puerto Rico
Affected count
36 kits
Manufactured in
1 N Waukegan Rd, North Chicago, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1288-2014

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