FDA is strengthening warnings in the febuxostat (Uloric) product labeling and has added a Medication Guide requirement because of an increased risk of cardiovascular death and all-cause mortality.

Apotex Corp. voluntarily recalled drospirenone and ethinyl estradiol tablets.

FDA issued recall of Raindrop Near Vision Inlay by RVO 2.0 due to corneal haze.

FDA issued recall of Kratom products by Sunstone Organics due to salmonella.

FDA issued recall of drospirenone and ethinyl estradiol tablets by Apotex Corp due to missing/Incorrect tablet arrangement.

FDA issued recall of LIFEPAK15 by Physio-Control due to risk of device failure.

FDA issued recall of GoLean Detox capsules by GoLean Detox USA due to undeclared ingredients.

FDA issued recall of losartan potassium/hydrochlorothiazide tablets, 100mg/25mg by Macleods Pharmaceuticals due to NDEA impurity.

FDA issued recall of ChemoLock Vial Spike by ICU Medical due to particle risk.

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

The FDA is notifying the public that Dr. Reddy’s Laboratories Ltd. is voluntarily recalling levetiracetam injection bags due to mislabeling.

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.