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 ALIMTA 785 mg and 1000 mg intravenous infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Pertuzumab IV bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Ondansetron 8 mg/50 mL infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Methylprednisolone 10 mg/0.16 mL IVP products due to a lack of assurance of sterility. The recall is limited to New York.
Infusion Options, Inc. is recalling ORENCIA 750 mg IV infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Azacitidine syringes 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 Dacarbazine infusions in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling specific Ramucirumab infusion products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling multiple Trastuzumab infusion bags 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 Panitumumab 400 mg/100 mL IV products in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Injectafer 720 mg and 210 mg IV products 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 various Cisplatin infusion products due to a lack of assurance of sterility. The recall is limited to New York.
Infusion Options, Inc. is recalling Infliximab 300 mg/250 mL infusion bags due to a lack of assurance of sterility. The recall affects New York.
Infusion Options, Inc. is recalling various Remicade infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various Bevacizumab infusion bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Perjeta 420 mg/250 mL IV bags in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling Atezolizumab 1200 mg/250 mL in New York due to a lack of assurance of sterility.
Infusion Options, Inc. is recalling various Carboplatin infusion bags because the company cannot guarantee the products are sterile.
Infusion Options, Inc. is recalling Doxorubicin Liposomal and combination chemotherapy infusions in New York due to a lack of assurance of sterility.
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 Ferric Carboxymaltose 750mg/50ml NS IVPB due to a lack of assurance of sterility. The product was distributed in New York.
Infusion Options, Inc. is recalling GAZYVA 100 mg and 900 mg infusion products in New York due to a lack of assurance of sterility.