FDA Drug recall D-1289-2014

LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for…

FDA Drug
Class II
terminated
Published 2014-05-07

On 2014-05-07 the FDA classified a Class II recall of LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for… by Abbvie, citing defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1289-2014
Classification	Class II
Status	terminated
Initiated	2014-03-10
Published	2014-05-07
Last updated	2026-09-13 11:51 UTC
Company	Abbvie
Distribution	US

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

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

Identifiers

upc	300743779035
ndc	0074-2108-03
ndc	0074-2282-03
ndc	0074-2440-03
ndc	0074-3779-03
ndc	0074-9694-03
ndc	0074-3575-01
ndc	0074-3410-01
ndc	0074-0010-01
code_info	Lot #:1013566, Exp 12/08/16

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1289-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.