US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 10, 2014 (12 years ago)

Lupron Depot

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
AbbVie Inc
NDC code
0074-3663-03
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1290-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Leuprolide recalls

See all
Class III · Low risk Terminated

Eligard

Reason Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

Tolmar, Inc. NDC 62935-753-75 D-1178-2023
Class II · Moderate risk Terminated

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit

Reason Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Perry Drug Inc. NDC 88888-1124-57 D-0262-2015
Class II · Moderate risk Terminated

Lupron Depot

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

AbbVie Inc NDC 0074-3642-03 D-1291-2014
Class II · Moderate risk Terminated

Lupron Depot-Ped

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

AbbVie Inc NDC 0074-3779-03 D-1289-2014
Class II · Moderate risk Terminated

Lupron Depot

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

AbbVie Inc NDC 0074-3473-03 D-1288-2014