America’s Unsafe Medical Products

April 30, 2019 by Paul Ausick

Source: courtesy of the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has issued three new safety alerts, all related to product recalls, including a device used in infants to enlarge the opening between the upper two chambers of the heart.

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 April 29. 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.

AmEx Pharmacy Recalls Macular Degeneration Drug
> Issue date: April 29, 2019
> Type of alert: Recall

One lot of Bevacizumab 1.25mg/0.05mL 31G injectable syringes are being recalled due to additional force necessary to inject the drug that could result in eye damage while the needle is in the eye. The drug is used to treat wet age-related macular degeneration and diabetic retinopathy. The lot number being recalled is 190212AB and had been distributed to ophthalmologist clinics in Pennsylvania, Illinois, Texas, Wisconsin, Kansas, Tennessee, Indiana and Arizona.

Teva Pharmaceuticals Recalls Losartan Tablets
> Issue date: April 29, 2019
> Type of alert: Recall

Teva Pharmaceuticals is voluntarily recalling six lots of 25 mg and 29 lots of 100 mg losartan tablets after detecting an impurity in the drugs manufactured by Hetero Labs. Losartan is used to treat hypertension.

Atrioseptostomy Dilatation Catheters Recalled
> Issue date: March 29, 2019
> Type of Alert: Recall

All catheters made by Edwards Lifesciences between December 22, 2017, and January 18, 2019, and distributed between January 8, 2018, and February 25, 2019, are being recalled because of possible difficulty in deflating the balloon, which could lead to balloon fragmentation or detachment when attempting to retrieve it. One serious injury to an infant was reported. This is a Class I recall, which means that continuing to use the devices may cause serious injury or death.

Legacy Pharmaceutical Packaging Recall
> Issue date: April 24, 2019
> Type of alert: Recall

Legacy Pharmaceutical Packaging is expanding its recall of three lots of 50 mg Losartan tablets to include a fourth lot related to a recall of the tablets by Torrent Pharmaceuticals due to the detection of a contaminant in the tablets.

Alvogen Recalls Fentanyl Transdermal Patch System
> Issue date: April 19, 2019
> Type of alert: Recall

Alvogen is voluntarily recalling two lots (180060 and 180073) of its 12 mcg/h fentanyl transdermal patch system with an expiration date of May and June 2020. Some of the cartons contain 50 mcg/h doses. According to the FDA, using the higher dosage patch “could result in serious, life threatening, or fatal respiratory depression.”

Torrent Pharmaceuticals Recalls More Losartan Tablets
> Issue date: April 18, 2019
> Type of alert: Recall

Torrent Pharmaceuticals has expanded its recall of 50 mg Losartan tablets to include 36 lots of Losartan potassium tablets and 68 lots of Losartan potassium/hydrochlorothiazide tablets due to possible contamination.

Brainlab Recalls Surgical Navigation Software
> Issue date: April 15, 2019
> Type of Alert: Recall

Brainlab is recalling its Brainlab Spine & Trauma 3D Navigation software used in its systems to help surgeons safely navigate surgical tools and implants used before and during minimally invasive surgical procedures. The recall covers 60 systems sold in the United States. The FDA classifies this as a Class I recall, which means that using the devices may cause serious injury or death.

Addyi (Flibanserin) Labeling Change
> Issue date: April 11, 2019
> Type of alert: Safety communication

Addyi from Sprout Pharmaceuticals is known as the female Viagra. The FDA has determined that the product’s labeling must be changed to reflect continuing concerns about the consumption of alcohol near in time to taking Addyi. The boxed warning, contraindication, warnings and precautions and adverse reactions sections of labeling are being updated to reflect that women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening.

Medical Devices Used to Test for and Diagnose Head Injuries
> Issue date: April 10, 2019
> Type of alert: Safety communications

FDA-approved devices used to assess, diagnose or manage head injuries such as concussion, traumatic brain injury and mild traumatic brain injury do not yet include any devices that may be used without an evaluation by a health care provider. Unapproved devices include smartphone or tablet-based apps that are said to be capable of determining changes in mental/cognitive status, including changes to vision, concentration, memory, balance and speech.

Aphrodisiac Capsules Marketed by SD Import
> Issue date: April 9, 2019
> Type of alert: Recall

SD Import is voluntarily recalling all lots of its Aphrodisiac Capsules because the product has been found to be tainted with sildenafil, an FDA-approved drug for erectile dysfunction. The recalled capsules have not been approved to contain sildenafil.

Glucose/Warfarin Monitor Test Strips
> Issue date: April 8, 2019
> Type of alert: Safety warning

The FDA is warning users (and caregivers) not to use test strips for these monitoring devices that were either previously owned but unused or test strips that are not authorized for sale in the United States. The strips are often available online marketplace sellers at Amazon, eBay or Craigslist and may be unsafe to use. The FDA warning provides further details.

Security Vulnerabilities Affecting Medtronic Implantable Cardiac Devices
> Issue date: March 21, 2019
> Type of alert: Safety communication

The FDA has confirmed cybersecurity vulnerabilities with the use of wireless telemetry from Conexus used to transmit data from implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. If the vulnerabilities were to be exploited, an unauthorized party could potentially access and manipulate an implantable device, home monitoring system or clinic programmer. Medtronic, the maker of the devices, has issued a security bulletin related to the issue.

Risks of Venclexta Treatment for Multiple Myeloma
> Issue Date: March 21, 2019
> Type of alert: Drug safety statement

The FDA is warning researchers and patients of the risks associated with the investigational use of Venclexta, a product of Abbvie and Genentech, in treating multiple myeloma base on data from a clinical trial. The drug has not been approved for the treatment of multiple myeloma. Patients currently taking the drug for approved uses should continue to do so.

Blue Fusion Dietary Supplement Capsules
> Issue date: March 21, 2019
> Type of alert: Recall

Ata Int. is voluntarily recalling all lots of Bluefusion capsules because the product is tainted with sildenafil, tadalafil and other compounds used to treat erectile dysfunction. The ingredients are undeclared active ingredients in the product that has not been approved for safety and efficacy.


DG/Health Naturals Baby Cough Syrup + Mucus
> Issue Date: March 20, 2019
> Type of alert: Recall

Kingston Pharma is recalling lot KL 180157 of this product because it may be contaminated with bacteria that can produce two forms of gastrointestinal illness with symptoms of vomiting or diarrhea. No illnesses have been reported to date.

Mylan Recalls Levoleucovorin Injection
> Issue date: March 18, 2019
> Type of alert: Recall

Mylan is voluntarily recalling two lots of its levoleucovorin 250 mg per 25 mL injection due to the presence of copper salts in the solution. The drug is used to treat cancer, among other things, and the salts found during stability testing could cause severe consequences, including pulmonary embolism.

Cook Medical Recalls Transseptal Needles
> Issue date: March 18, 2019
> Type of alert: Recall

Cook Medical is voluntarily recalling 97 transseptal needles used to access the left side of a patient’s heart during cardiac procedures. Due to a manufacturing flaw, the needle tips are missing the back bevel that creates a sharp tip. The recall was initiated by the company on February 1.

Hospira 8.4% Sodium Bicarbonate Injection
> Issue date: March 15, 2019
> Type of alert: Recall

Hospira, a division of Pfizer, is voluntarily recalling three lots of the sodium bicarbonate solution due to glass contamination. The solution is delivered intravenously to treat metabolic acidosis.

Treating Peripheral Arterial Disease With Paclitaxel-Coated Devices
> Issue date: March 15, 2019
> Type of alert: Letter to health care providers

In a letter to health care providers on January 17, 2019, the FDA notified peripheral interventionists and vascular medicine physicians of a “possible increased mortality rate after two years” compared to patients treated with non-coated balloons or bare-metal stents. Further analysis of three trials now reveals a 50% increase in mortality risk in patients treated with paclitaxel-coated devices after five years.

Legacy Pharmaceutical Packaging 50 mg Losartan Tablets
> Issue date: March 15, 2019
> Type of alert: Recall

Three lots of 50 mg Losartan tablets used to treat high blood pressure were voluntarily recalled due to possible contamination of the medication manufactured by Hetero Labs.

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.

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 100 mg/25 mg 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 10 mg 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.

Dr. Reddy’s Levetiracetam (Antiepileptic)
> Issue date: February 5, 2019
> Type of alert: Recall

Dr. Reddy’s Laboratories, an India-based firm, is voluntarily recalling due to mislabeling its levetiracetam single-dose infusion bags sold in the United States. The amount of sodium chloride in the affected products indicates a concentration of 0.75% on the infusion bag itself and 0.54% (the correct content) on the external foil pouch. There have been no reports of adverse effects from this recall of Dr. Reddy’s antiepileptic treatment.

Abiomed Impella Right Heart Pump System
> Issue date: February 4, 2019
> Type of alert: Letter to providers

The FDA notified cardiologists, cardiothoracic surgeons and transplant surgeons that recent post-approval testing of Abiomed’s Impella heart pump system shows results suggesting a higher mortality rate for patients than in the premarket clinical studies. In pre-approval testing, the survival rate past 30 days was 73.3%; in the post-approval testing, the survival rate is 17.4%. The difference may be attributable to tighter restrictions on patients selected for the pre-approval testing.

Smith’s Medical Sterile Saline and Water
> Issue date: February 4, 2019
> Type of alert: Recall

Smith’s Medical is recalling the solution that is used in humidification products (full list) for patients undergoing respiratory therapy, tracheal wash or wound cleaning. The products may have been exposed to infectious agents due to damage to the containers the company used to package the product. A voluntary recall was begun in September 2017. The recent alert upgrades the action to a Class I recall, the FDA’s most serious category. Using these products may cause injury or death.

Letco Medical Gluthathione-L-Reduced Powder for Compounding Sterile Drugs
> Issue date: February 1, 2019
> Type of alert: Warning

The FDA is warning compounders not to use Letco Medical’s glutathione-L-reduced powder to compound sterile injectable drugs for patients. The powder has been supplied to about 100 compounders in 30 states. The FDA has received seven reports of patients experiencing adverse effects, which the agency believes is due to high levels of endotoxin (a toxin present inside a bacterial cell that is released when the cell disintegrates). FDA testing has begun.

Stryker LIFEPACK 15 Monitors/Defibrillators
> Issue date: February 1, 2019
> Type of alert: Recall

Stryker is voluntarily recalling the monitor/defibrillators to update the system’s firmware. The company has received 58 complaints of a device lock-up (blank monitor while power indicators are lighted; no response from the keypad; and no device functions). There are 13,003 devices affected by this recall.

Roche Diagnostics CoaguChek XS PT Test Strips
> Issue date: February 1, 2019
> Type of alert: Recall

The strips manufactured by Roche were sold by Terrific Care or Medex Supply to test patient response to warfarin blood thinner. The distributors are recalling 759 boxes because the test strips are delivering inaccurate results compared to laboratory results.

West Pharmaceutical Services Fluid Transfer Systems
> Issue date: February 1, 2019
> Type of alert: Recall

The company is recalling 38.8 million Vial2Bag fluid transfer systems because the devices may not adequately transfer concentrated medication from a vial to an IV bag before infusion into a patient’s vein. The FDA received 16 complaints of serious problems when the 13mm device was used with oxytocin for pregnant women during labor and delivery.

Infants’ Ibuprofen
> Issue date: January 30, 2019
> Type of alert: Recall

Tris Pharma issued a voluntary recall of three lots of infants’ ibuprofen in early December of last year. The dosage may exceed the label-specified description. The drug was sold at Family Dollar (Family Wellness brand), CVS (CVS Health brand) and Walmart (Equate brand). Tris Pharma has received no reports of adverse effects.

Nature’s Rx Silver Bullet 10x Male Enhancement Drug
> Issue date: January 29, 2019
> Type of alert: Recall

The company is conducting a voluntary recall of its Silver Bullet 10x male enhancement drug because the product contained undeclared amounts of sildenafil and tadalafil, the active ingredients in Viagra and Cialis, respectively.  The ingredients pose a serious health risk to users taking other drugs that, for example, may lower a person’s blood pressure to dangerous levels.

Draeger Medical Breathing and Anesthesia Sets
> Issue date: January 25, 2019
> Type of alert: Recall

The company is recalling 1,200 VentStar and ID breathing circuits and anesthesia sets sold in the United States to provide mechanical ventilation and critical breathing support to patients. The devices may have been incorrectly assembled, resulting in a short-circuit in the breathing hose. That may lead to irreversible patient harm, up to and including death. This is a Class I recall.

Torrent Pharmaceuticals Losartan Tablets
> Issue date: January 22, 2019
> Type of alert: Recall

Torrent is expanding a voluntary recall of two types of losartan tablets used to treat hypertension. Six lots of losartan potassium and hydrochlorothiazide tablets were 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.

Treating Peripheral Arterial Disease
> Issue date: January 17, 2019
> Type of alert: Letter to health care providers

The FDA notified peripheral interventionists and vascular medicine physicians that a recent meta-analysis of randomized trials of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease suggests a “possible increased mortality rate after two years” compared to patients treated with non-coated balloons or bare-metal stents.

Medtronic Cranial Surgery Navigation System
> Issue date: January 8, 2019
> Type of alert: Recall

Medtronic’s Synergy cranial system and StealthStation S7 cranial software are being recalled following reports that incorrect information is being displayed during biopsy procedures. If the defect should occur, “the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient’s healthy tissue, brain or blood vessels.” The recall was initiated in September 2018 and has been designated a Class I recall, the FDA’s most serious category. Using these devices may cause injuries or death.

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