HHP Medication Safety Watch: April 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
• Prescription 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 serious infection, particularly among people with skin wounds or scrapes or who have a suppressed immune system.

Hand sanitizer recalled due to contamination with methanol, benzene, and acetaldehyde

• Ulta Beauty Collection & SS Scented Hand Sanitizer (maker: Scentsational Soaps & Candles, Inc.)

Comment: This product may be contaminated with methanol (wood alcohol), benzene, and acetaldehyde. Drinking a product that contains methanol can cause vomiting, headache, or blurred vision. More severe toxicity includes permanent blindness, seizures, coma, or death. In rare cases, toxicity could occur after applying contaminated rubbing alcohol to the skin. Young children are at particular risk of accidental poisoning by these products. People with alcohol addiction and adolescents are also at high risk. Benzene and acetaldehyde exposure have been linked to cancer.

See additional FDA recalls and alerts for more than 230 hand sanitizer products in recent months due to methanol contamination, inappropriate labeling, or other issues.

Dietary supplements for male sexual enhancement may contain undeclared prescription medications

• IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 Dietary Supplements for Male Sexual Enhancement (maker: QMART)
• PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 Dietary Supplements for Male Sexual Enhancement (maker: Yolo Studio)
• Premium OrgaZen 7000 and Ginseng Power 5000 capsules Dietary Supplements for Male Sexual Enhancement (maker: NS NY Distributor Inc)

Comment: According to the FDA, these products may contain sildenafil and/or 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.

Each of these recalled products 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.

Acetaminophen recalled due to incomplete label information

• Acetaminophen Extra Strength 500 mg tablets (maker: A-S Medication Solutions, LLC)

Comment: This recall is due to incomplete information on the medicine label. Acetaminophen is generally considered safe if people follow the correct instructions on the label, such as not taking more the recommended upper limit per day, avoiding use while drinking excessive alcohol, and not taking this medicine if allergic to it. These safety recommendations help protect people against the potential for liver damage while taking acetaminophen.

Prescription medicines

Guanfacine recalled due to contamination with quetiapine

• Guanfacine Extended Release tablets 2 mg (maker: Apotex Corp.)

Comment: This action was taken because some lots of this medicine contain small amounts of quetiapine fumarate. The combination of these two medicines could cause allergic reactions, low blood pressure, dizziness, and sedation. Older adults, children, and pregnant women are more likely than others to experience these side effects.

Extended-release guanfacine is prescribed for attention deficit hyperactivity disorder (ADHD). Quetiapine (Seroquel) is prescribed for schizophrenia, bipolar disorder, and other mental health conditions.

Thyroid tablets recalled because they may contain too little medication

• NP Thyroid (maker: Acella Pharmaceuticals, LLC)

Comment: Certain lots of this medicine have been recalled because routine testing found that they contained less thyroid hormone than they should. A person receiving treatment with thyroid hormone whose dose is too low may experience problems such as fatigue, sensitivity to cold, and constipation. More serious complications, such as heart failure, may occur, especially among elderly individuals who receive less thyroid medicine than intended. Pregnant women whose thyroid treatment is underdosed have a higher than usual risk of early miscarriage, or of having a baby with certain health issues and developmental abnormalities.

Read additional issues of HHP Medication Safety Watch