Alkermes Recalls VIVITROL Vials Due to Dose Delivery Failure
Alkermes is recalling 4,364 vials of VIVITROL (naltrexone) nationwide because customer complaints reported the product failed to deliver the dose.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of therapeutic failure for a prescription medication.
Plain-English summary
Alkermes, Inc. is recalling 4,364 vials of VIVITROL (naltrexone for extended-release injectable suspension), 380 mg, distributed nationwide. The recall is being conducted due to customer complaints that the product failed to deliver the intended dose.
The affected product is identified by Batch Number 412-3732AA with an expiration date of 07/2016. Specific NDC numbers associated with the recall include 65757-302-02 and 65757-300-01. The recall is classified as FDA Class II.
Patients and healthcare providers should stop using the affected vials and contact their healthcare provider or Alkermes for further instructions. The recall is limited to the specific batch and expiration date listed above.
The recalled product
- Product
- VIVITROL (NALTREXONE)
- Brand
- VIVITROL
- Manufacturer
- Alkermes, Inc.
- Category
- Drug — Prescription Injectable
- Hazard
- Affected units
- 4,364
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)
- Batch Number: 412-3732AA
- expiration date 07/2016 (NDC# 65757-302-02
- Kit Pacaging Lot Number: 2013-021
- expiration date 07/2016 (NDC# 65757-300-01.
Distribution
Distributed nationwide across the United States.
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