Alkermes Recalls VIVITROL Vials Due to Sterility Assurance Concerns
Alkermes, Inc. is recalling 3,325 vials of VIVITROL (naltrexone) because the product failed container closure integrity testing, raising concerns about sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of assurance of sterility in an injectable drug, which poses a risk of harm (infection) even though no specific illnesses or injuries are reported in the source text.
Plain-English summary
Alkermes, Inc. is voluntarily recalling 3,325 vials of VIVITROL (naltrexone for extended-release injectable suspension). The recall involves 380 mg vials (NDC 65757-303-02) and 380 mg vials in kits (NDC 65757-300-01). The affected lots are 402-3683AA (expiration 10/13) for individual vials and 2011-003 (expiration 08/13) for kit vials. The product was distributed nationwide.
The recall was initiated because the product did not meet the criteria for container closure integrity testing during routine 24-month stability testing. This failure indicates a lack of assurance of sterility for the affected units.
Healthcare providers and patients should stop using the affected lots of VIVITROL. Alkermes, Inc. is the recalling firm responsible for managing the recall.
The recalled product
- Product
- VIVITROL (NALTREXONE)
- Brand
- VIVITROL
- Manufacturer
- Alkermes, Inc.
- Category
- Drug — Prescription Injectable
- Affected units
- 3,325
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 (4)
- Individual vial lot 402-3683AA
- EXP 10/13
- kit vial lot 2011-003
- EXP 08/13
Distribution
Distributed nationwide across the United States.
Related recalls
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- ModerateAlkermes Recalls Vivitrol Kits Due to Needle Labeling Error
FDA (Drugs) · 2019-10-09
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FDA (Drugs) · 2019-09-04
- SevereAlkermes Recalls VIVITROL Vials Due to Dose Delivery Failure
FDA (Drugs) · 2014-09-03
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