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VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02,...

FDA Recall #D-819-2013 — Class II — November 6, 2012

Recall #D-819-2013 Date: November 6, 2012 Classification: Class II Status: Terminated

Product Description

VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,

Reason for Recall

Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.

Recalling Firm

Alkermes, Inc. — Waltham, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3,325 vials

Distribution

Nationwide

Code Information

Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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