AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device
AbbVie is recalling 36 kits of Lupron Depot 45 mg due to a potentially defective needle stick protection device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (needle stick injury) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
AbbVie Inc. is recalling 36 kits of Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit, 45 mg for 6-month administration. The affected product is identified by Lot # 1013976, with an expiration date of 09/25/15, and was distributed nationwide and in Puerto Rico.
The recall was initiated because some kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. This defect poses a risk of needle stick injuries to healthcare providers or patients using the product.
Consumers and healthcare providers should stop using the affected kits and contact their healthcare provider or AbbVie for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- LUPRON DEPOT (LEUPROLIDE ACETATE)
- Brand
- LUPRON DEPOT
- Manufacturer
- AbbVie Inc
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 36
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 # 1013976
- Exp 09/25/15
UPCs (1)
- 300743473032
Distribution
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
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- ModerateAbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device
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FDA (Drugs) · 2014-05-07
- ModerateAbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection
FDA (Drugs) · 2014-05-07
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