Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Doxorubicin 110 MG / 55 ML IVP SYRINGE; Doxorubicin 56 MG / 28 ML IVP SYRINGE; Doxorubicin 75 MG / 37.5 ML IVP SYRINGE; Doxorubicin 125 MG / 62.5 ML SYRINGE IVP; Doxorubicin 93 MG / 46.5 ML IV SYRINGE; Doxorubicin 112 MG / 56 ML IVP SYRINGE; Doxorubicin 50 MG / 25 ML IVP SYRINGE; Doxorubicin 120 MG / 60 ML IVP SYRINGE; Doxorubicin 106 MG / 53 ML IVP SYRINGE; Doxorubicin 90 MG / 45 ML IVP SYRINGE; Doxorubicin 14 MG/500 ML NS IV WITH Vincristine 0.7 MG and Etoposide 70 MG; Doxorubicin 100 MG / 50 ML IVP SYRINGE; Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG; Doxorubicin 45 MG / 22.5 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
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: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Reason Cross Contamination with Other Products: trace amounts of octreotide found during testing
Reason Lack of Assurance of Sterility
Reason Lack Of Assurance Of Sterility
Reason Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled…
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