America’s Unsafe Medical Products

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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.

Golean Detox Capsules
> Issue date: February 25, 2019
> Type of Alert: Recall

Golean Detox USA voluntarily has issued a recall of all lots of its capsules following an FDA analysis that the capsules are tainted with substances that have been withdrawn by the agency from the U.S. market. The company said it has received no reports of adverse effects related to the recall.

Macleod’s Pharmaceuticals Losartan 100mg/25mg Tablets
> Issue date: February 25, 2019
> Type of Alert: Recall

The company is voluntarily recalling of two types of losartan tablets used to treat hypertension. One lot of losartan potassium and hydrochlorothiazide tablets has been found to have trace amounts of an unexpected carcinogen in tablets manufactured by Hetero Labs. The company has received no reports of adverse events related to this recall.

Pfizer Xeljanz and Xeljanz XR
> Issue date: February 25, 2019
> Type of Alert: Safety alert

The FDA is alerting patients, health care professionals, pharmacists and rheumatologist that Pfizer’s Xeljanz and Xeljanz XR increase the risk of blood clots in the lungs and death for patients with rheumatoid arthritis taking a twice-daily 10mg dose of the drug.

Total Thermal Imaging Inc. (TTI) Thermography Business Package
> Issue date: February 25, 2019
> Type of Alert: Warning

TTI has failed to take promised steps to replace misleading marketing messages for its thermography package. The company has mischaracterized the product as a stand-alone screening device for diagnosing breast cancer. The FDA has approved thermography only for use with another diagnostic tool. TTI faces severe sanctions if it fails to respond within 15 days to the FDA’s warning letter.

ICU Medical’s 20mm ChemoLock Vial Spike
> Issue date: February 25, 2019
> Type of alert: Recall

The company is recalling 2,050 units of its CL-80S ChemoLock Vial Spike due to the potential for plastic particles to break off the protective cap, potentially entering the drug delivery system and infused into a patient’s intravenous line resulting in “serious injury or death.” ICU Medical has received no reports of adverse effects related to this issue. The devices are commonly used in pharmacies that compound their own medicines and by health care facilities.

Takeda Uloric
> Issue date:
February 21, 2019
> Type of alert: Safety announcement

Uloric is prescribed to treat gout and was approved by the FDA in 2009 on condition of conducting a post-release study. The results of that study found “an increased risk of death” from heart-related problems or deaths from any cause among patients using Uloric (febuxostat) compared to another treatment, allopurinol (brand name Zyloprim). The FDA is now requiring Takeda to include a Boxed Warning for Uloric and restricting approved use of the drug only to those patients for whom allopurinol is not effective or who suffer severe side effects from allopurinol.

Breast Implants (All Types)
> Issue date: February 7, 2019
> Type of alert: Letter to providers

The FDA is notifying health care providers in a number of specialties of reports indicating that patients with breast implants have an increased risk of developing breast implant associated–anaplastic large cell lymphoma (BIA-ALCL) with the scar tissue next to the implant. The FDA has received 457 unique medical device reports on implants, among whom nine deaths may be attributable to BIA-ALCL.