The Recall Desk
ModerateFDA (Drugs)·D-1289-2014·Announced 2014-05-07

AbbVie Recalls Lupron Depot-Ped Kits Due to Defective Needle Protection

AbbVie is recalling 12 kits of Lupron Depot-Ped due to a potentially 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, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The defect is in the needle protection device, posing a risk of needle stick injury, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

AbbVie Inc. is recalling 12 kits of LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), a prescription medication used for 3-month administration. The product is a single-dose administration kit with a prefilled dual-chamber syringe, manufactured for AbbVie Inc. and by Takeda Pharmaceutical Company Limited.

The recall is being issued because some of the kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. The affected product is identified by Lot #1013566 with an expiration date of 12/08/16. The kits were distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled description, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
LUPRON DEPOT-PED (LEUPROLIDE ACETATE)
Brand
LUPRON DEPOT-PED
Manufacturer
AbbVie Inc
Category
Drug — Prescription Injection
Hazard
Affected units
12

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 (2)

  • Lot #:1013566
  • Exp 12/08/16

UPCs (1)

  • 300743779035

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 manufacturer · AbbVie Inc

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Same hazard · needle stick

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