Class I — High risk. Reasonable probability of serious harm or death.
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Lack of sterility assurance
Reason Lack of sterility assurance
Reason Presence of Particulate Matter: Identified as Glass Particles
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