Question 1

Is Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01 recalled?

Accepted Answer

Alkermes Inc. is recalling 6,514 units of Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial kits. The recall was initiated because 1-inch needles were accidentally placed inside cardboard sleeves labeled as 1.5-inch administration needles. While the medication vial itself is not impacted, using the incorrect needle length may affect the proper administration of the medication. These prescription kits were distributed nationwide across the United States.

Question 2

What should I do?

Accepted Answer

Check your Vivitrol (naltrexone) 380 mg/vial kit for Lot Number 2018-3010T with an expiration date of 8/2021 and Kit NDC 65757-300-01. Open the kit and inspect the cardboard sleeves labeled for 'administration needles' to verify if the needle inside matches the 1.5-inch length described on the sleeve. Contact your healthcare provider or pharmacist immediately for guidance if you find the incorrect needle size or if you have already used a kit from this lot. Return any unused product kits from Lot 2018-3010T to your pharmacy for a refund and to obtain a replacement with the correct components. Contact Alkermes Inc. directly if you have further questions regarding this recall or need assistance with the return process. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Question 3

How do I get a refund or replacement?

Accepted Answer

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

Alkermes Inc: Vivitrol Injection Kits Recalled Due to Incorrect Needle Size in Packaging

Summary

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