HHP Medication Safety Watch: May 2021

This list contains selected items from the full FDA list of recalls, withdrawals, and alerts for medicines and certain health products. We've provided links to FDA information for each product and its maker. Unless otherwise noted, these actions apply only to the specific brand name of the product listed. Talk to your healthcare provider before stopping or changing any medicines or treatments that they have recommended for you.

• Over-the-counter products and medicines

Over-the-counter products and medicines

Hand sanitizer recalled due to bacterial contamination

• Durisan Hand Sanitizer (maker: Sanit Technologies LLC d/b/a Durisan)

Comment: This product may be contaminated with bacteria called Burkholderia contaminans. While using it may cause no serious harm, it's possible that the bacteria could enter the bloodstream and cause a serious infection, particularly among people with skin wounds or scrapes, or those who have a suppressed immune system. This action is an expansion of an earlier recall.

Hand sanitizers may be contaminated with methanol (wood alcohol) or other chemicals

• Medically Minded hand sanitizer, 8.5 oz. (maker: Global Sanitizers)
• Medically Minded hand sanitizer, 8, 8.5, and 10 oz. (maker: Global Sanitizers)
• Goose Creek and COCO TKO Hand Sanitizers (maker: Scentsational Soaps & Candles, Inc.)
• DIBAR Labs, ProtectoRx Hand Sanitizer (maker: Dibar Nutricional S. de R.L. de C.V.)

Comment: Drinking a product that contains methanol can cause nausea, vomiting, or blurred vision. More severe toxicity includes permanent blindness, seizures, coma, or death. In rare cases, toxicity could develop from applying contaminated hand sanitizer to the skin. Infants and young children are at particular risk of accidental poisoning by these products. People with alcohol addiction and adolescents are also at high risk.

In addition to methanol, Goose Creek and COCO TKO Hand Sanitizers may also contain benzene and acetaldehyde. Exposure to these chemicals has been linked to cancer and blood disorders.

See additional FDA recalls and alerts for more than 250 hand sanitizer products in recent months due to methanol contamination, bacterial contamination, inappropriate labeling, or other problems.

Dietary supplement for male sexual enhancement may contain undeclared prescription medicines

• Poseidon Male Sexual Enhancement Dietary Supplement (maker: Yamtun7)

Comment: This product may contain sildenafil and tadalafil, prescription medicines to treat erectile dysfunction (ED). Sildenafil and tadalafil may cause a dangerous drop in blood pressure, especially if taken with nitrate medicines. Other side effects may include headache, flushing, or stomach upset.

This recalled product is marketed as a nutritional supplement to improve male sexual function.

In recent months, multiple medications marketed for male sexual enhancement have been recalled due to the presence of prescription ED medications. See this link for a full list.

Dietary supplement for weight loss may contain undeclared prescription medicines

• Imperia Elita Vitaccino Coffee (maker: Dash Xclusive)

Comment: This product is marketed as a nutritional supplement for weight loss but may be contaminated with sibutramine and fluoxetine.

Sibutramine was approved by the FDA in 1997 as a weight loss drug, but it was withdrawn from the market in 2010 because it was found to increase the risk of stroke, heart attack,, and other problems. Side effects of sibutramine include increased blood pressure and heart rate, shortness of breath, and chest pain, especially among people with previous heart disease or stroke.

Fluoxetine is a prescription drug approved to treat depression, obsessive compulsive disorder, panic disorders, and bulimia. Side effects may include an increased risk of suicide, restlessness, and neurologic disorders.

Read additional issues of HHP Medication Safety Watch