Accord Healthcare, Inc.: Drug Recall

Recall #D-0131-2023 · 11/29/2022

Class I: Dangerous

Recall Details

Recall Number
D-0131-2023
Classification
Class I
Product Type
Drug
Recalling Firm
Accord Healthcare, Inc.
Status
Terminated
Date Initiated
11/29/2022
Location
Durham, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Unknown

Reason for Recall

Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial

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

Distribution Pattern

Nationwide within the United States

Other Recalls by Accord Healthcare, Inc.

View all recalls by Accord Healthcare, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.