FDAFDA · Food and drugs·Recall number D-0131-2023
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
Published January 25, 2023 · Recall initiated: November 29, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot: R2200232 Exp. 01/2025
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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