The FDA has announced a recall of three lots of Genentech Activase® (alteplase) 100mg vials, co-packaged with Sterile Water for Injection. The Sterile Water vial, packaged by Hospira, may be cracked or chipped at the neck and leaking. Lot numbers are 3128243, 3141239, and 3166728. For full details see https://www.fda.gov/Safety/Recalls/ucm574980.htm .
The FDA has published a safety communication on potassium-lowering drug Kayexalate and other brands of sodium polystyrene sulfonate because it has been found to bind to other oral medications, reducing their effectiveness. The FDA recommends separating the dosing of sodium polystyrene sulfonate from other orally administered medicines by at least 3 hours. They are updating sodium polystyrene sulfonate drug labels to include information about this dosing separation. For details see https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574763.htm .
The FDA has announced a recall of alcohol pads and benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products, due to the absence of sterility assurance, and risk of infection. For details see https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm574576.htm .
The FDA has announced the recall of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A because of the possible presence of particulate matter (glass). For details see https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574261.htm .
Because of instruction-manual issues which may lead to cassette damage that could result in the delivery of air into patients, the FDA has announced Class II recalls of:
- Baxter HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R – https://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_157849 .
- HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R – https://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_157690 .
The FDA has announced the Class II recall of Arrow International Hemodialysis Catheterization Kits because of danger of needlestick injury. For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_154713 .
The FDA has warned that the diabetes drug Canagliflozin (Invokana, Invokamet) is associated with increased risk of amputation. For details see https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558605.htm .