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 Mitomycin 10 mg/20 mL IVP syringes in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various Cyclophosphamide infusion products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various Methotrexate injection products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling specific Rituximab infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Topotecan 1.24 mg/100 mL infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Adcetris 96 mg/100 mL IV infusion bags due to a lack of assurance of sterility. The product was distributed in New York.
Infusion Options, Inc. is recalling Oxytocin 60 units/1000 mL Lactated Ringers IV Solution because the product lacks assurance of sterility. The recall affects 820 bags distributed in New York.
Infusion Options, Inc. is recalling multiple lots of oxaliplatin infusion bags due to a lack of assurance of sterility. The recall is limited to New York.
Infusion Options, Inc. is recalling Dacarbazine infusions 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 Durvalumab infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Diphenhydramine 25 mg/50 mL NS infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling RomiPLOStim 700 MCG/1.4 ML SQ syringes in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling specific Abraxane 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 various Velcade subcutaneous syringes 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 Vinblastine infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Iron Sucrose 200 mg/100 mL IV products due to a lack of assurance of sterility. The recall is limited to New York.
Infusion Options, Inc. is recalling various Docetaxel infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various Cisplatin infusion products due to a lack of assurance of sterility. The recall is limited to New York.
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 HERCEPTIN infusion bags 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 Granisetron 1000 mcg/50 mL NS infusion products in New York due to a lack of assurance of sterility.