The Recall Desk
ModerateFDA (Drugs)·D-1287-2014·Announced 2014-05-07

AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection

AbbVie is recalling 7,362 Lupron Depot kits because some may contain a syringe with a defective needle stick protection device.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a defective safety device (needle stick protection) rather than a direct chemical or biological contamination. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

AbbVie Inc. is recalling 7,362 kits of Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit. The recall is due to a potential defect in the LuproLoc needle stick protection device on the prefilled dual-chamber syringes contained in some kits.

The affected product is the 22.5 mg for 3-month administration, prescription-only formulation. The specific lots involved are 1014204 (Exp 10/11/15), 1014485 (Exp 12/11/16), and 1015007 (Exp 12/06/16). The product was distributed nationwide and in Puerto Rico.

Healthcare providers and patients should check their inventory and medication kits for these specific lot numbers. If a kit is found to be affected, it should not be used. Consumers and healthcare professionals should contact AbbVie or their healthcare provider for further instructions on how to proceed.

The recalled product

Product
LUPRON DEPOT (LEUPROLIDE ACETATE)
Brand
LUPRON DEPOT
Manufacturer
AbbVie Inc
Category
Drug — Prescription Injectable
Hazard
Affected units
7,362

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

UPCs (1)

  • 300743346039

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by AbbVie Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same brand · LUPRON DEPOT

Same manufacturer · AbbVie Inc

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Same hazard · needle stick

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