HHP Medication Safety Watch: March 2023

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 recalls due to contamination

• Midwest Cleaning Solutions Alcohol Antiseptic 80% Topical Solution hand sanitizer (maker: Jarman's Midwest Cleaning Systems, Inc.)
• Midwest Cleaning Solutions Isopropyl Alcohol Antiseptic 75% Topical Solution hand sanitizer (maker: Jarman's Midwest Cleaning Systems, Inc.)
• Clean Pro Supply Alcohol Antiseptic 80% Topical Solution hand sanitizer (maker: Jarman's Midwest Cleaning Systems, Inc.)

Comment: The maker of these products recalled them due to contamination with methanol (wood alcohol).

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

See additional FDA recalls and alerts for more than 400 hand sanitizer products in recent years due to methanol or benzene contamination, bacterial contamination, inappropriate labeling, or other problems.

Anti-inflammatory eye drops recalled due to contamination

• Purely Soothing 15% MSM Eye Drops (maker: Pharmedica USA LLC)

Comment: Two lots of this product have been recalled due to contamination that could cause an eye infection. A severe infection could cause blindness.

This product is used to treat eye irritation and inflammation.

Prescription medicines

Eye drops recalled due to possible contamination

• Apotex Brimonidine Tartrate Ophthalmic Solution, 0.15% (maker: Apotex Corp.)

Comment: Six lots of this product have been recalled because of cracks found in their bottle caps. These cracks may mean that the liquid in the bottle is not sterile and use of these eye drops could cause an infection. A severe infection may cause blindness.

These medicated eye drops treat higher than normal eye pressure (a condition called ocular hypertension) and glaucoma.

Blood thinner recalls due to an impurity

• Dabigatran capsules, 75 mg (maker: Ascend Laboratories LLC)
• Dabigatran capsules, 150 mg (maker: Ascend Laboratories LLC)

Comment: The maker of these products has recalled them after detecting a nitrosamine, called N-nitroso-dabigatran, in higher than acceptable levels. Nitrosamines are found at low levels in water and foods. However, exposure to higher than acceptable levels over time may cause cancer.

These medicines are blood-thinners that are prescribed to reduce the risk of blood clots and stroke.

Antibiotic recalled due to possible contamination

• Atovaquone Oral Suspension, 750mg/5mL (maker: Camber Pharmaceuticals, Inc.)

Comment: The maker of this antibiotic has recalled one lot of this product due to possible contamination with the bacterium Bacillus cereus. Using this product could cause a serious or even life-threatening infection, especially among people with a weakened immune system.

Atovaquone is prescribed to prevent and treat pneumocystis pneumonia, a rare illness caused by the fungus Pneumocystis jiroveci.

Read additional issues of HHP Medication Safety Watch