Manufacturers/Alkermes, Inc.

Alkermes, Inc.

10 drugs in NADAC|0 Generic,10 Brand

View Recalls (3)

Total Drugs

10

0G / 10B

Avg Price / Unit

$695.4773

$55.03 – $1719.46

Avg 7d Change

0.00%

Across 0 drugs with changes

7d Activity

10 flat

of 10 total drugs

Portfolio Price Trend

Monthly average NADAC price across all drugs

Drug Portfolio

10 drugs total, 10 shown

FDA Recalls (3)

Recalls matched by company name. Verify current status with FDA.

D-0119-2020
Terminated
Class II

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

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: 9/26/2019
D-1556-2014
Terminated
Class II

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.

Customer complaints for failure to deliver the dose.

Initiated: 3/4/2014
D-819-2013
Terminated
Class II

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,

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

Initiated: 11/6/2012