Drug 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
D-0131-2023
Product summary
- Event
- Event 91228
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0131-2023
Official wording
Reason: Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Code information: Lot: R2200232 Exp. 01/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling mixup