FDA Recall D-0131-2023
Accord Healthcare, Inc. · Durham, NC
Class I — life-threatening Terminated 450 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
Reason for recall
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Recall record
- Recall number
D-0131-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2022-11-29
- Classified by FDA Center
- 2023-01-13
- FDA published
- 2023-01-25
- Terminated
- 2024-02-22
- Recalling firm
- Accord Healthcare, Inc.
- Firm location
- Durham, NC