Alkermes recalls
FDA enforcement reports naming Alkermes Inc as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 0
- Most recent report
- Oct 9, 2019
- Oct 9, 2019Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vialDrug · Alkermes, Inc.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.Class II
- Sep 4, 2019Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vialDrug · Alkermes IncLabeling: 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.Class II
- Sep 3, 2014VIVITROL (naltrexone for extended-release injectable suspension)Drug · Alkermes, Inc.Customer complaints for failure to deliver the dose.Class II
- Jul 31, 2013VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 657…Drug · Alkermes, Inc.Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.Class II