Alkermes Recalls Vivitrol Kits Due to Needle Labeling Error
Alkermes is recalling 16,231 Vivitrol kits because 1-inch needles were incorrectly placed in sleeves labeled for 1.5-inch needles. The drug vials are not affected.
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 involves a minor labeling/packaging error where the drug vial is explicitly stated to be unaffected, fitting the criteria for moderate severity.
Plain-English summary
Alkermes, Inc. is recalling 16,231 kits of Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. The recall involves Lot 2019-1002T and 2019-1003T, which have an expiration date of 05/2021. The kits were distributed nationwide in the United States and in Canada.
The recall was initiated due to a labeling and packaging error. Specifically, 1-inch needles were placed in the cardboard sleeve designated for 1.5-inch administration needles. The source text explicitly states that the product vial itself is not impacted by this issue.
Healthcare providers and patients should stop using the affected kits and contact Alkermes for instructions on how to return the product. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VIVITROL (NALTREXONE)
- Brand
- VIVITROL
- Manufacturer
- Alkermes, Inc.
- Category
- Drug — Prescription Injectable
- Affected units
- 16,231
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 2019-1002T
- 2019-1003T
- Exp 05/2021
Distribution
Distributed nationwide across the United States.
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