Alkermes Recalls
4 recalls on record · July 31, 2013 to October 9, 2019 · Drugs
Recalls by year
13
14
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 9, 2019DrugsFDA
Alkermes, Inc. recalls Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 m
Hazard: 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.
September 4, 2019DrugsFDA
Alkermes Inc recalls Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 m
Hazard: 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.
September 3, 2014DrugsFDA
Alkermes, Inc. recalls VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured an
Hazard: Customer complaints for failure to deliver the dose.
July 31, 2013DrugsFDA
Alkermes, Inc. recalls VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit
Hazard: Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.