FDA Drug Class II — Moderate

Lupron Depot (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 0074-3663-03, UPC 3 00743 66303 7.

Hazard

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

Products

Lupron Depot (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.,
Brand
AbbVie Inc
UPC
Lot #: 1013906, Exp 09/21/16

Units Affected

1,530 kits