Medications & Supplements/Prescription Drugs

Alkermes, Inc.: Vivitrol (naltrexone) Injection Kits Recalled Due to Incorrect Needle Size

Agency Publication Date: October 2, 2019

Summary

Alkermes, Inc. is recalling 16,231 kits of Vivitrol (naltrexone for extended-release injectable suspension) 380 mg because some kits contain the wrong needle size. One-inch needles were accidentally placed in cardboard sleeves labeled as 1.5-inch administration needles, which could lead to improper drug delivery. This recall affects specific lots distributed across the United States and Canada, though the medication vial itself is not affected.

Risk

If a healthcare provider uses a shorter 1-inch needle when a 1.5-inch needle is required for an intramuscular injection, the medication may be delivered into the fatty tissue rather than the muscle. This could result in the patient receiving an incorrect dose or experiencing skin-level irritation at the injection site.

What You Should Do

Check your Vivitrol 380 mg/vial carton for Kit NDC 65757-300-01 and the following lot numbers: 2019-1002T or 2019-1003T with an expiration date of 05/2021.
If you are a patient, contact your healthcare provider or pharmacist immediately to determine if your medication kit is affected and to discuss your treatment plan.
If you have an affected kit, return any unused product to the pharmacy where it was purchased for a refund and to obtain a replacement.
Healthcare providers should inspect their inventory and stop using the administration needles from the identified lots if they appear shorter than labeled.
Contact the manufacturer, Alkermes, Inc., for further instructions regarding the return and replacement process.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider guidance and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial

Model:

NDC 65757-300-01

Recall #: D-0119-2020

Lot Numbers:

2019-1002T (Exp 05/2021)

2019-1003T (Exp 05/2021)

Date Ranges: Expiration 05/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83878

Status: Resolved

Manufacturer: Alkermes, Inc.

Sold By: Pharmacies; Healthcare providers

Manufactured In: United States

Units Affected: 16,231 kits

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your Vivitrol 380 mg/vial carton for Kit NDC 65757-300-01 and the following lot numbers: 2019-1002T or 2019-1003T with an expiration date of 05/2021.

If you are a patient, contact your healthcare provider or pharmacist immediately to determine if your medication kit is affected and to discuss your treatment plan.

If you have an affected kit, return any unused product to the pharmacy where it was purchased for a refund and to obtain a replacement.

Healthcare providers should inspect their inventory and stop using the administration needles from the identified lots if they appear shorter than labeled.

Contact the manufacturer, Alkermes, Inc., for further instructions regarding the return and replacement process.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.