AbbVie Recalls Lupron Depot Kits With Defective Needle Protection
AbbVie is recalling 1,530 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The defect involves a needle stick protection device, which is a safety mechanism failure rather than a direct contamination or dosage error.
Plain-English summary
AbbVie Inc. is recalling 1,530 kits of Lupron Depot (leuprolide acetate) 11.25 mg for 3-Month administration. The recall is due to a defect in the delivery system where some kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
The affected product is identified by Lot # 1013906 with an expiration date of 09/21/16. The kits were distributed nationwide and in Puerto Rico.
Consumers and healthcare providers should stop using the affected kits and contact AbbVie or their healthcare provider for further instructions.
The recalled product
- Product
- LUPRON DEPOT (LEUPROLIDE ACETATE)
- Brand
- LUPRON DEPOT
- Manufacturer
- AbbVie Inc
- Category
- Drug — Prescription Injection
- Affected units
- 1,530
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 #: 1013906
- Exp 09/21/16
UPCs (1)
- 300743663037
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
Same brand · LUPRON DEPOT
- ModerateAbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device
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- ModerateAbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection
FDA (Drugs) · 2014-05-07
- HighAbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device
FDA (Drugs) · 2014-05-07
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