Two drugs, a dietary supplement, and some devices have been recalled because of mislabeled dosages, hidden ingredients, possible injury, and more. The recalled items are used for high blood pressure, herpes infections, sexual enhancement, preoperative swabs, and cardiac surgery in children
The first recall concerns telmisartan, the brand name Micardis, which is used to control high blood pressure. This voluntary recall is due to a misnomer. Alembic, the maker of telmisartan, discovered that bottles marked for 20 mg tablets actually contain 40 mg tablets. The 20 mg tablets are round and the 40 mg tablets are oval.
In addition to its use in high blood pressure, it is also used to protect people over the age of 54 from cardiovascular problems such as heart attacks and strokes when they cannot take ACE inhibitors to protect against these events.
The correct dosage is important because people who take the wrong prescription are at risk of having low blood pressure, decreased kidney function, or high potassium levels, which can become life-threatening. Those who do regular blood pressure checks at home may experience lower blood pressure levels. People often feel dizzy with low blood pressure.
Telmisartan is available in tablets of 20 mg, 40 mg and 80 mg. The usual dose for high blood pressure is 40 mg once a day and for cardiovascular risk reduction 80 mg a day.
Alembic said it had not received any reports of adverse events or side effects related to this labeling error.
Recall of IV antiviral drugs
Four lots of the antiviral drug acyclovir (IV) are being recalled by Zydus Pharmaceuticals due to crystallization which can cause blood vessel damage. This medication treats herpes in its various forms and shingles in immunocompromised patients.
The drug comes as a powder in a small bottle. Sterile water is added and the powder is expected to completely dissolve. It is then given intravenously as a liquid (IV).
It should be obvious if there are particles or crystals present. If it doesn’t completely dissolve, the undissolved crystals can cause damage as the blood moves through the body.
The blockages can cause clots, especially in the lungs. Clots can cause strokes, heart attacks, impair the functioning of the liver and kidneys, and much more.
Zydus Pharmaceuticals has not received any reports of adverse events related to this product recall. The four batches will expire in December 2021 and January 2022. The bottles contain 50 mg / ml medication, either 20 ml or 10 ml.
Recall of the male sex enhancer
An FDA analysis of PremierZen Black 5000, advertised as a sexual enhancement supplement, contained prescription drugs for erectile dysfunction. Hidden ingredients are not allowed in dietary supplements, so manufacturer Namoo Enterprise LLC has issued a nationwide recall of PremierZen. The analysis revealed both sildenafil and tadalafil, better known as Viagra and Cialis.
Taking a dietary supplement that contains these unlisted prescription drugs can cause serious health problems, especially in patients taking nitrates for high blood pressure, heart disease, and diabetes. The FDA advises that those using this product should destroy it.
The company said it had not received any reports related to the recall.
Class I remembers pediatric surgical devices
Medtronic has issued a major Class I recall for its Affinity Pixie Oxygenator and Cardiotomy / Venous Reservoir with Balance Biosurface due to the risk of infection from the device. The infection would be caused by endotoxins, the evil membrane of some nasty pathogens like Salmonella, Escherichia coli, and Shigella.
These endotoxins are released by bacteria and, in addition to fever and infections, trigger an acute systemic toxic reaction and death.
These devices are used on newborns, infants, and young children undergoing open heart surgery. Cardiopulmonary bypass is used when the child’s heart needs to rest during open heart surgery. Affinity acts like the heart and lungs, providing oxygen, removing carbon dioxide, but temporarily during surgery. The FDA is urging hospitals to identify and quarantine unused products.
The company has reported that there are no complaints, reports of injuries or deaths related to this recall.
Recall of the applicator used to prepare the skin prior to surgery has been expanded
The ChloraPrep 3ml Applicator Recall has been expanded to include all unexpired products in all 50 US states due to the risk of potential fungal contamination (Aspergillus penicillioides). This recall has been expanded twice by its maker, Becton, Dickinson and Company. The first was in June 2020. At that time, the recall only affected certain catalog numbers and locations with six months of an even temperature of 30 ° C and 75% humidity. The product is a skin disinfectant that is used before catheter and surgical procedures.
The second recall was made last week to all US states. And now it covers all unexpired products.
It was the company that found the problem with humidity and high heat. Removal of the swab from the package can contaminate the swab or the gloved hand of the person using the swab.
No adverse events have been reported, according to the FDA.
Yvonne Stolworthy MSN, RN graduated from Nursing School in 1984 and spent many years in critical care and as an educator in a variety of settings including clinical trials.