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
Reported: January 25, 2023 Initiated: November 29, 2022 #D-0131-2023
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
Details
- Recalling Firm
- Accord Healthcare, Inc.
- Units Affected
- Unknown
- Distribution
- Nationwide within the United States
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Accord Healthcare, Inc.. Units affected: Unknown.
Why was this product recalled? ▼
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2023. Severity: Critical. Recall number: D-0131-2023.
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