Recalls That Should Be on Your Radar—Week of June 30, 2019

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Macleods Pharmaceutical Limited Issues Recall of Losartan Products Due to NMBA Impurity

Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots of 50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity was found in 32 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration'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.

Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets, USP should continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

Read more about this recall here.

Growers Express Issues Recall of Fresh Vegetable Products Due to Potential of Listeria Monocytogenes

Growers Express takes issues of food safety seriously and is issuing a voluntary recall of select fresh vegetable products in an abundance of caution and in the interest of protecting its customers and end consumers. The fresh vegetable products include packaged varieties of butternut squash, cauliflower, zucchini and a butternut squashed based veggie bowl. Please refer to the detailed chart below for specific product names and retailers.

The products originate from a Growers Express production facility in Biddeford, Maine and were distributed to the states referenced in the chart below. The voluntary recall was issued due to the potential for contamination with Listeria monocytogenes. There are no reported illnesses.

Read more about this recall here.

Fresenius Kabi Issues Recall of 2 Lots of Fluorouracil Injection Due to Risk of Glass Particulate

Fresenius Kabi USA, LLC is voluntarily recalling two lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, to the user level due to the potential for glass particulate.

Products containing glass particulate should not be administered intravenously due to the potential for life-threatening consequences. Reports in the literature suggest that sequelae of thromboembolism, such as pulmonary emboli, phlebitis, granulomas, or fibrosis may occur.

To date, Fresenius Kabi has not received any complaints or reports of adverse events related to this recall.

Read more about this recall here.

Edwards Lifesciences Issues Recall for IntraClude Intra-Aortic Device Due to Risk of Balloon Rupture

Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon rupture during use, which may add time to the procedure and compromises the safety of the patient.

The IntraClude balloon bursting may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage, embolism, stroke and death.

The firm has received 22 complaints related to balloon rupture or puncture. Three deaths have been reported.

Read more about this recall here.

Becton Dickinson & Company Issues Recall for SmartSite Syringe Due to Risk of Leaks

Becton Dickinson’s (BD) SmartSite Syringe Administration Sets are used with an infusion pump to deliver fluids including medications, blood and blood products into a patient’s body in a controlled manner. The pump administers fluid into a patient’s vein or other cleared routes of administration via an infusion tubing set. The infusion sets are intended to be used with the BD Alaris or Medley Syringe Pumps, Module 8110. The devices are used in hospitals and other health care facilities.

This product is primarily used to provide critical therapies to patients in the Neonatal Intensive Care Unit (NICU).

Read more about this recall here.

Vyaire Medical Issues Recall of enFlow Warming System Due to Risk of Exposure to Elevated Levels of Aluminum

The enFlow Fluid Warming System is indicated for warming blood, blood products and intravenous solutions prior to IV administration to a patient. It is intended to be used by healthcare professionals in hospital, clinical, and field environments to help prevent hypothermia. The enFlow Disposable Cartridge incorporates an aluminum extrusion. The enFlow cartridge is sterile, disposable and is used with the enFlow fluid warmer.

Vyaire Medical is recalling the Vyaire Medical enFlow Disposable Cartridges due to the potential for aluminum to elute from the warmer into the fluids, there by exposing patients to unsafe levels of aluminum.

Exposure to unsafe levels of aluminum may result in serious adverse health consequences including, but not limited to, muscle weakness, various neurocognitive and bone marrow complications, or death.

No injuries or deaths have been reported.

Read more about this recall here.