America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) has announced a voluntary recall of 160 mg valsartan tablets used to control high blood pressure.

The FDA issues safety alerts to provide timely new safety information on human drugs, medical devices, vaccines and other products, including biologics, dietary supplements and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.”

The following list includes all MedWatch alerts for 2019 through March 6. There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The 2019 alerts are listed in reverse chronological order, so the most recent are listed first. Included are the type of alert and the issue date.

American Health Packaging 160 mg Valsartan Tablets
> Issue date: March 8, 2019
> Type of alert: Recall

One lot of valsartan tablets manufactured by Aurobindo Pharma and distributed by American Health Packaging have been voluntarily recalled due to trace amounts of an unexpected impurity in the finished product that is classified as a possible human carcinogen. Valsartan is used to treat high blood pressure in some patients, who are advised by the FDA to continue taking their medicine because the risk to their health if they stop suddenly may be greater than the risk of taking the recalled medication. The lot number being recalled is 179791.

Zoll LifeVest 4000
> Issue date: March 6, 2019
> Type of alert: Safety communication

A problem in the charging circuitry of the LifeVest 4000 could lead to a failure of the device to deliver an electrical shock to restore a patient’s normal heart rhythm. The device is the only wearable defibrillator available in the United States and is used by patients who cannot or will not accept an implantable defibrillator. Patients are being reminded to call Zoll immediately if a LifeVest 4000 displays the following error message: Call for Service — Message Code 102. More than 33,000 units were included in the original recall.

Sunstone Organics Kratom
> Issue Date: March 1, 2019
> Type of alert: Recall

Two lots of kratom (lot 119 of Sunstone Organics White Vein Kratom and lot 124A of Sunstone Organics Maeng Da Kratom) in both powder and capsule form in all sizes potentially may be contaminated with salmonella. The products were distributed to retail outlets in Oregon, Washington, California and Nebraska. According to an FDA statement from November 2017, kratom is “has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death.” The U.S. Drug Enforcement Agency failed in a 2016 effort to ban the substance.

RVO 2.0 Inc. Raindrop Near Vision Inlays
> Issue date: Not provided
> Type of alert: Recall

The company’s inlays are implanted into the cornea of one eye to improve near vision in patients who wear glasses or contact lenses by reshaping the cornea. The recall includes 2,869 units of the device and is being done because data from a new study showed a higher risk to patients of corneal haze, an inflammation of the cornea that causes cloudiness in a person’s vision. This is a Class I recall, indicating that use of the device may cause serious injuries or death.