FDA (Drugs) recall action 83136
The FDA (Drugs) publishes a recall like this one as 76 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 76 pages.
Lack of Assurance of Sterility
The agency’s own wording, quoted from the enforcement report.
Infusion Options, Inc. is recalling OPDIVO 200 mg and 480 mg infusion products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various Avastin infusion products because of a lack of assurance of sterility. The recall is limited to New York.
Infusion Options, Inc. is recalling specific vincristine infusion products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Cytarabine products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling specific paclitaxel protein infusion products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Entyvio 300 mg/250 mL due to a lack of assurance of sterility. The product was distributed in New York.
Infusion Options, Inc. is recalling Bleomycin 18 Units / 100 mL NS IVPB products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Nivolumab IV bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Cetuximab 335 mg/167.5 mL IV infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various Gemcitabine infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling SOLIRIS 1200 mg and 900 mg IV products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Granisetron 1000 mcg/50 mL NS infusion products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling preservative-free 0.9% sodium chloride 5 mL syringes in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various strengths of Carfilzomib infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling specific IV fluid products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Ifosfamide and Mesna infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Paclitaxel Albumin infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Bortezomib subcutaneous syringes in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various Rituxan infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling ERBITUX infusion bags in New York due to a lack of assurance of sterility.
The FDA is recalling DARATUMUMAB infusion solutions because sterility cannot be assured, creating a potential infection risk.
Infusion Options, Inc. is recalling Vinblastine infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling FOSAPREPITANT 150 mg/150 ml NS IVPB in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling DARZALEX 1008 mg / 500 mL IV infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Decitabine 40 mg/100 ml infusions in New York due to a lack of assurance of sterility.