Alkermes, Inc.
Alkermes, Inc. appears in FDA public data with 4 recalls, 0 510(k) clearances, 14 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0119-2020, Class II) was initiated on September 26, 2019.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 14
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0119-2020 | Class II | Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: | September 26, 2019 |
| D-1846-2019 | Class II | Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: | August 8, 2019 |
| D-1556-2014 | Class II | VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX | March 4, 2014 |
| D-819-2013 | Class II | VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) | November 6, 2012 |