CDC has issued a Health Alert Network or HAN bulletin on the Rising Numbers of Deaths Involving Fentanyl and Fentanyl Analogs, Including Carfentanil, and Increased Usage and Mixing with Non-opioids. Find the bulletin at https://content.govdelivery.com/accounts/USCDC/bulletins/1fde19f.
The FDA has required new label warnings about blood sugar and mental health side effects of fluoroquinolone antibiotic drugs. The most common fluoroquinolones are Cipro (ciprofloxacin), Avelox (moxifloxacin), and Levaquin (levofloxacin), but there are many others, most of which end in -floxacin. The new label has many specific warnings and recommendations for diabetics. For full details see https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm.
The FDA has announced the recall of one lot, 1060 cases (4240 bottles), of NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liter, lot code 18CXAC095, because it is mislabeled with an incorrect part number. For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164557.
The FDA has announced a recall of Fresenius Liberty Select PD Cycler (SW v.2.8.7), Material Number RTLR108343 because of the possibility of overfill, which can result in serious injury or death. For details and serial numbers see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=162848.
The FDA has announced recalls of all lots and serial numbers of the following Baxter Prismaflex products, for installation of new firmware:
- Prismaflex System, Product Code 107493; https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164043
- Prismaflex 5.10 US, Product Code 113081; https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164044
- Prismaflex 7.XX ROW, Product Code 114870; https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164045
- Prismaflex 7.XX US, Product Code 115269; https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164046
- Prismaflex 7.20 US, Product Code 955542; https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164047
The FDA does not include a link to recall instructions.
Certain lots of Accu-Chek Aviva and Performa test strips have been recalled by Roche Diabetes Care because some strips may give error messages or incorrect readings, which could result in treatment errors. Lots recalled include:
- Accu-Chek Aviva 10 test strip pots, lots #497344, 497392
- Accu-Chek Aviva 50 test strip pots, lots #496802, 496807, 496809, 496915, 497391, 497392
- Accu-Chek Performa 10 test strip pots, lots #476597, 476646
- Accu-Chek Performa test strips in Nano blood glucose kits, lots #10153111, 10153112, 10153114, 10153115, 10153116
The FDA has announced a recall of 3,440 units of Baxter Prismaflex high permeability Dialyzer Control Units, with or without a sealed dialysate system, because of software errors and an apparent likelihood of operator errors. For product codes and other information, see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=153275.