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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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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- HighAbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device
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