FDA-Drug2023-01-25Class I
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
Accord Healthcare, Inc.
Hazard
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Sold states
Nationwide within the United States
Affected count
Unknown
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0131-2023Don't want to check this manually?
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