Vivitrol Kit
FDA Recall NDC 65757-301

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 4 recorded enforcement report(s) associated with Vivitrol (NDC 65757-301). A significant event, classified as Class II, was initiated on Sep 26, 2019 by Alkermes, Inc.. The reported reason for this action was: "Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted."

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-0119-2020TERMINATEDD-1846-2019TERMINATEDD-1556-2014TERMINATEDD-819-2013TERMINATED

September 2019 Class II Recall: Labeling

Recall Number
D-0119-2020
Class II Terminated
Reason for Recall
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Initiated
Sep 26, 2019
Reported
Oct 09, 2019
Quantity
16,231 kits

Recall Profile & Regulatory Data

Event ID
83878
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Alkermes, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Canada
Termination Date
Feb 19, 2021
Product Description
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
Batch or Lot Expiration Information
Lot# Lot 2019-1002T, 2019-1003T, Exp 05/2021
Affected Packages Involved in this Recall
65757-300-01Product
65757-302-02Product
65757-304-03Product
65757-301-01Product
65757-303-02Product
65757-305-03Product

August 2019 Class II Recall: Labeling

Recall Number
D-1846-2019
Class II Terminated
Reason for Recall
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Initiated
Aug 08, 2019
Reported
Sep 04, 2019
Quantity
6,514 kits

Recall Profile & Regulatory Data

Event ID
83511
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Alkermes Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Nov 06, 2020
Product Description
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
Batch or Lot Expiration Information
Lot# Lot 2018-3010T Exp 8/2021
Affected Packages Involved in this Recall
65757-300-01Product
65757-302-02Product
65757-304-03Product
65757-301-01Product
65757-303-02Product
65757-305-03Product

March 2014 Class II Recall: Customer complaints for failure to deliver the dose.

Recall Number
D-1556-2014
Class II Terminated
Reason for Recall
Customer complaints for failure to deliver the dose.
Initiated
Mar 04, 2014
Reported
Sep 03, 2014
Quantity
4,364 vials

Recall Profile & Regulatory Data

Event ID
67838
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Alkermes, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 22, 2014
Product Description
VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
65757-300-01Product
65757-302-02Product
65757-304-03Product
65757-301-01Product
65757-303-02Product
65757-305-03Product

November 2012 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-819-2013
Class II Terminated
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.
Initiated
Nov 06, 2012
Reported
Jul 31, 2013
Quantity
3,325 vials

Recall Profile & Regulatory Data

Event ID
65092
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Alkermes, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 28, 2013
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,
Batch or Lot Expiration Information
Lot# Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
Affected Packages Involved in this Recall
65757-300-01Product
65757-302-02Product
65757-304-03Product
65757-301-01Product
65757-303-02Product
65757-305-03Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.