America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) has updated a voluntary recall on a wearable defibrillator designed to treat arrhythmias. The device, made by Zoll, was voluntarily recalled in January 2018.

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 with the most recent listed first. Included are the type of alert and the issue date.

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.

Apotex Drospirenone and Ethinyl Estradiol Tablets
> Issue date: March 1, 2019
> Type of alert: Recall

Apotex is recalling four lots of its Drospirenone and Ethinyl Estradiol tablets because the blister packaging may contain defective or empty blisters. The error could cause patients to miss taking a tablet or to take a placebo tablet instead, resulting in a loss of efficacy.

Expanded Recalls of Valsartan and Losartan
> Issue date: March 1, 2019
> Type of alert: Update

AurobindoPharma USA has expanded its voluntary recall to include 38 additional lots of its valsartan and amlodipine-valsartan combination tablets. Torrent Pharmaceuticals also expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets to an additional 144 lots. Both recalls are related to contaminated products.

Angiotensin Receptor Blockers (ARBs)
> Issue date: February 28, 2019
> Type of alert: Update

The FDA has updated its limits for interim acceptable intake limits for impurities in a number of ARB products, including Valsartan, Losartan, Irbesartan and others.