Alkermes Recalls Vivitrol Kits Due to Incorrect Needle Packaging
Alkermes is recalling 6,514 Vivitrol kits because 1-inch needles were incorrectly placed in sleeves labeled for 1.5-inch needles. The drug vials are not impacted.
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, but the source text explicitly states the product vial is not impacted and the issue is limited to needle packaging/labeling, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Alkermes Inc is recalling 6,514 kits of Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. The recall is due to a labeling and packaging error where 1-inch needles were placed in the cardboard sleeve labeled for 1.5-inch administration needles. The product vials themselves are not impacted by this issue.
The affected product is identified by Lot 2018-3010T with an expiration date of 8/2021. The kits were distributed nationwide in the USA. Each kit contains one vial of Vivitrol, one vial of diluent, one 5-mL prepackaged syringe, one 20-gauge 1-inch needle, two 20-gauge 1.5-inch safety needles, and two 20-gauge 2-inch safety needles.
Consumers and healthcare providers should check their inventory for Vivitrol kits with Lot 2018-3010T. If found, they should stop using the kits and contact Alkermes Inc for further instructions on how to return the product.
The recalled product
- Product
- VIVITROL (NALTREXONE)
- Brand
- VIVITROL
- Manufacturer
- Alkermes Inc
- Category
- Drug — Prescription Injectable
- Affected units
- 6,514
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 (1)
- Lot 2018-3010T Exp 8/2021
Distribution
Distributed nationwide across the United States.
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