AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device
AbbVie is recalling 2,915 Lupron Depot kits because the syringe needle protection device may be defective. The recall covers nationwide distribution and Puerto Rico.
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. The hazard involves a defective safety device (needle stick protection) rather than a direct chemical or biological contamination of the drug itself, and no injuries are reported in the source text.
Plain-English summary
AbbVie Inc. is recalling 2,915 kits of Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit. The product is a prescription medication manufactured for AbbVie Inc. and distributed nationwide and in Puerto Rico. The specific lots affected are 1012381 and 1012383, with an expiration date of 08/22/16.
The recall was initiated because some kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. This defect relates to the safety mechanism designed to protect healthcare workers from needle sticks.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates 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 (LEUPROLIDE ACETATE)
- Brand
- LUPRON DEPOT
- Manufacturer
- AbbVie Inc
- Category
- Drug — Prescription Injection
- Affected units
- 2,915
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 (3)
- Lot #: 1012381
- 1012383
- Exp 08/22/16
UPCs (1)
- 300743642032
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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