D-0131-2023 Class I Terminated
FDA drug recall D-0131-2023 was initiated by Accord Healthcare, Inc. on Nov 29, 2022 and is designated Class I. Reason for recall: Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial The recall status is terminated (terminated Feb 22, 2024). Affected quantity: Unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 25, 2023
- Initiation Date
- Nov 29, 2022
- Termination Date
- Feb 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot: R2200232 Exp. 01/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0131-2023
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026