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FDA Safety Alerts

April 30, 2019

These Food and Drug Administration (FDA) safety alerts came in recently:

 

Safety Recall: Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter

Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. The firm has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the femoral and iliac veins; additional procedures to retrieve the fragments; permanent patient disability; pulmonary embolism; stroke; damage to other organs; or death. One serious injury was reported in which an infant underwent an invasive, but successful surgical procedure to retrieve a detached balloon. There were no deaths reported. More Information.

 

Safety Recall: ThermaCare HeatWraps

Pfizer Inc. is voluntarily recalling 1 lot of ThermaCare Back Pain Therapy HeatWraps due to the potential that a HeatWrap could include cells that have a higher cell temperature than specified. The use of a wrap with a cell with increased temperature poses a potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap applied area. More Information.

 

Teva Losartan Recall

Teva Pharmaceuticals USA Inc. has initiated a voluntary recall in the U.S. of 35 lots of losartan potassium tablets. This recall is due to the detection of an impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) found in 6 lots of active pharmaceutical ingredient manufactured by Hetero Labs Limited that is above the U.S. FDA’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out. More Information.

 

Safety Recall: Bevacizumab Monoject Syringes

AmEx Pharmacy is voluntarily recalling 1 lot of bevacizumab 1.25mg/0.05mL Monoject Syringes. The Monoject Syringe for this product may become difficult to express, and when additional force is applied, may cause injury to the patient. More Information.