# FDA recall D-1289-2014

> **AbbVie Inc** · Class II · drug recall initiated 2014-03-10.

## 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 for recall

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

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1289-2014
- **Recalling firm:** AbbVie Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-03-10
- **Report date:** 2014-05-07
- **Termination date:** 2016-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1289-2014

## Citation

> AI Analytics. FDA recall D-1289-2014. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-1289-2014. Source: US FDA. Licensed CC0.

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