News: Recalls

FDA issued recall of dual chamber implantable pulse generators by Medtronic due to circuit error.

FDA issued recall of levetiracetam in 0.54% sodium chloride injection 1500mg/100mL by Dr. Reddy's Laboratories due to mislabeling.

FDA issued recall of Swan-Ganz thermodilution catheter by Edwards Lifesciences due to incorrect assembly.

FDA issued recall of sterile saline and sterile water for inhalation by Medex Cardio-Pulmonary, doing business as Smiths Medical due to potential exposure to infectious agents as a result of...

FDA issued recall of LIFEPAK® 15 monitor/defibrillator by Stryker due to lock up after a defibrillation shock is delivered.

FDA issued recall of CoaguChek XS PT Test Strips by Roche Diagnostics due to inaccurate test results.

FDA issued recall of Vial2Bag fluid transfer systems by West Pharmaceutical Services due to potential malfunctions.

FDA issued recall of Infants’ Ibuprofen Concentrated Oral Suspension by Tris Pharma due to potential higher concentrations of ibuprofen; three additional lots added.

FDA issued recall of Silver Bullet 10x by Nature’s Rx due to undeclared PDF-5 inhibitors.

FDA issued recall of VentStar and ID Breathing Circuits and Anesthesia Sets by Draeger Medical due to possible incorrect assembly.

FDA issued recall of irbesartan and irbesartan/hydrochlorothiazide (HCTZ) tablets by Prinston Pharmaceutical due to NDEA impurity.

FDA issued recall of Synergy Cranial software and Stealth Station S7 Cranial software by Medtronic due to inaccuracies displayed during surgical procedures.

FDA issued recall of Rhino 5k capsules by Happy Together due to presence of undeclared sildenafil and tadalafil.

FDA issued recall of vecuronium bromide for injection by Sun Pharmaceutical Industries due to particulate matter.

FDA issued recall of ceftriaxone for injection by Lupin Pharmaceuticals due to particulate matter.