Two medications , a dietary supplement, and some devices have been recalled for mislabeled dosages, hidden ingredients, potential injuries and much more . The recalled items span uses for high blood pressure, herpes infections, sexual enhancement, pre-surgical swabs and children ’s cardiac surgery
The first remember is for telmisartan, brand name Micardis, which can be used to control high blood pressure. This voluntary recall is because of a mislabeling error. Alembic, the maker of telmisartan, discovered that bottles labeled for 20 mg tablets actually contain 40 mg tablets. The 20 mg tablets are round and the 40 mg tablets are oval.
Apart from its use for high blood pressure, it is also given to protect people older than 54 years against cardiovascular related issues such as heart attack and stroke if they cannot take ACE inhibitors to protect against these events.
The right dosage is important , as people taking the wrong prescription risk having low blood pressure, decreased kidney function, or elevated amounts of potassium, which may become life-threatening. Individuals who regularly check their blood pressure at home could notice lower BP numbers. Individuals often feel dizzy with low BP.
Telmisartan is available in 20 mg, 40 mg, and 80 mg tablets. The usual dose for high blood pressure is 40 mg once a day and for cardiovascular risk reduction it’s 80 mg per day.
Alembic indicated it has not received any reports of adverse events or side effects associated with this labeling error.
Recall of IV antiviral medication
Four lots of the antiviral medication acyclovir (IV) are being recalled by Zydus Pharmaceuticals because of crystallization, which can cause blood vessel damage. This medicine treats herpes in its various manifestations and shingles in immunocompromised patients.
The medication comes as a powder in a small bottle. Sterile water is added and the powder is expected to dissolve completely. Then as a liquid it’s given intravenously (IV).
It needs to be evident if any crystals or particles are present . If it doesn’t dissolve completely, the undissolved crystals may cause damage as the blood moves through the body.
The blockages can cause clots, especially in the lungs. Clots can cause strokes, heart attacks, affect function in the liver and kidneys , and more .
Zydus Pharmaceuticals has not received any reports of adverse events associated with this product recall. The four tons expire in December 2021 and January 2022. The bottles contain 50 mg/mL of medication, either 20 mL or 10 mL.
Remember of male sexual enhancer
An FDA analysis of PremierZen Black 5000, advertised as a sexual enhancement dietary supplement, contained prescription drugs for erectile dysfunction. Hidden ingredients are not permitted in dietary supplements, and thus the manufacturer Namoo Enterprise LLC has issued a nationwide recall of PremierZen. The study turned up both sildenafil and tadalafil, more commonly known as Viagra and Cialis.
Taking a supplement that comprises these unlisted prescription medications can lead to serious health issues, especially for those taking nitrates for hypertension , heart disease and diabetes. The FDA advises that those with this product should destroy it.
The company said it hadn’t received any reports linked to the recall.
Class I recall on pediatric surgical device
Medtronic has issued a Class I recall, the most serious kind , for its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface due to risk for disease from the device. The infection would be due to endotoxins, the nasty membrane of several nasty pathogens, like salmonella, Escherichia coli and shigella.
These endotoxins are released from germs and besides fever and infection, start an acute systemic toxic reaction and departure .
These devices are used for newborns, infants and young children who have open heart surgery. Cardiopulmonary bypass is used if the child ’s heart needs to rest during open heart surgery. The Affinity acts like the lungs and heart , providing oxygen, removing carbon dioxide, but on a temporary basis during the surgery . The FDA is requesting that hospitals identify and quarantine artificial products.
The company has reported that no complaints, reports of accidents , or deaths associated with this recall.
Recall expanded of applicator used for pre-surgery skin prep
The recall of this ChloraPrep 3 mL applicator has been expanded to include all unexpired products in all 50 U.S. countries due to risk for possible fungal (Aspergillus penicillioides) contamination. This recall has been expanded twice by its producer , Becton, Dickinson and Company. The first was in June 2020. At that moment , the recall only influenced defined catalog numbers and areas with six months of straight 86°F / 30°C temperatures and 75% humidity. The product is a skin sensitizer used before catheter and surgical procedures.
The next recall was last week to all U.S. states. And today it covers all unexpired products.
It was the firm that found the problem with humidity and higher heat. Removing the swab from the package can contaminate the swab or the gloved hand of the individual using the swab.
No adverse events were reported, the FDA said.
Yvonne Stolworthy MSN, RN graduated from nursing school in 1984 and has spent several years in critical care and as an educator in many different settings, including clinical trials.