The FDA has announced the recall of one lot each of two antibacterials manufactured by Emcure Pharmaceuticals and distributed by Heritage Pharmaceuticals, because of non-sterility:
- Amikacin Sulfate Injection USP 250mg/mL Lot# VEAC025 Expiry October 2019
- Prochlorperazine Edisylate Injection USP 5mg/mL Lot# VPCA172 Expiry April 2020
For details see https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/heritage-pharmaceuticals-inc-issues-voluntary-nationwide-recall-amikacin-sulfate-injection-usp-1gm4.
The FDA has announced a recall of Medcomp 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422. For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=171580.
The FDA has announced a class II recall of lot Y281477, Expiry 02/2020, of Baxter Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only, Product Code 5B9766, NDC 0941-0424-52 due to leaks. For full details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=170205.
The FDA has announced a Class II recall of 4 lots of Fresenius Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E, Lot Numbers 18HU06016, 18HU06017, 18HU06018, and 18HU06019, because of blood leaks. For details see https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=169039.