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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67709

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 10, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AbbVie Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 5

Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 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 0074-3346-03, UPC 3 00743 34603 9.

D-1287-2014
Recall number
D-1287-2014
Initiated
March 10, 2014
Classification
Class II
Status
Terminated
Recalling firm
AbbVie Inc
Quantity
7362 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 1014204, Exp 10/11/15; 1014485, Exp 12/11/16; and 1015007, Exp 12/06/16

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 5

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.

D-1288-2014
Recall number
D-1288-2014
Initiated
March 10, 2014
Classification
Class II
Status
Terminated
Recalling firm
AbbVie Inc
Quantity
36 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # 1013976, Exp 09/25/15

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 5

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.

D-1289-2014
Recall number
D-1289-2014
Initiated
March 10, 2014
Classification
Class II
Status
Terminated
Recalling firm
AbbVie Inc
Quantity
12 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #:1013566, Exp 12/08/16

Distribution pattern

Nationwide and Puerto Rico

drug · product 4 of 5

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.

D-1290-2014
Recall number
D-1290-2014
Initiated
March 10, 2014
Classification
Class II
Status
Terminated
Recalling firm
AbbVie Inc
Quantity
1,530 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 1013906, Exp 09/21/16

Distribution pattern

Nationwide and Puerto Rico

drug · product 5 of 5

Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3642-03, UPC 3 00743 64203 2.

D-1291-2014
Recall number
D-1291-2014
Initiated
March 10, 2014
Classification
Class II
Status
Terminated
Recalling firm
AbbVie Inc
Quantity
2915 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 1012381, 1012383, Exp 08/22/16

Distribution pattern

Nationwide and Puerto Rico