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America’s Unsafe Medical Products – 24/7 Wall St.

The U.S. Food and Drug Administration (FDA) has issued two new recalls, one related to potential salmonella contamination and the other a medical device used to improve near vision.

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 1. 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 is listed first. Included are the type of alert and the issue date.

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.

Robotically Assisted Surgical Devices for Mastectomy Procedures
> Issue date: February 28, 2019
> Type of alert: Safety communication

The FDA is informing health care providers and patients that the safety and effectiveness of these devices has not been established either for mastectomy procedures or cancer prevention: “There is limited, preliminary evidence that the use of robotically assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival.”

Physio-Control LIFEPAK 15 Monitors/Defibrillators
> Issue date: February 27, 2019
> Type of alert: Recall

Physio-Control has recalled 8,164 monitor/defibrillators to update the system’s firmware. The device may lock up (blank monitor while power indicators are lighted and no response from the keypad and no device functions). This is a Class I recall, meaning that continued use of these devices may cause serious injury or even death.