Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack Of Processing Controls
Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
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 Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
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