HHP Medication Safety Watch: March 2022

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 may be contaminated with methanol (wood alcohol)

• Tennessee Technical Coatings Corp. hand sanitizer (maker: Tennessee Technical Coatings Corp.)

Comment: This product has been recalled because it is contaminated with methanol (wood alcohol). 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. 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 increased risk.

See additional FDA recalls and alerts for more than 280 hand sanitizer products in recent months due to methanol contamination, bacterial contamination, inappropriate labeling, or other problems.

Milk of magnesia, acetaminophen, and magnesium hydroxide/aluminum hydroxide/simethicone recalled due to contamination

• Major Pharmaceuticals’ Milk of Magnesia Oral Suspension 2400 mg/30 mL (maker: Plastikon Healthcare, LLC)
• magnesium hydroxide 1200mg/aluminum hydroxide 1200mg/simethicone 120mg per 30 mL (maker: Plastikon Healthcare, LLC)
• acetaminophen 650mg/20.3mL (maker: Plastikon Healthcare, LLC)

Comment: These three products are recalled due to contamination with bacteria or other infectious agents and failure to investigate its cause. Use of these medicines could cause diarrhea, abdominal pain, or even a life-threatening bodywide infection. People with an impaired immune system are at higher risk for severe illness.

These products have a different uses. Milk of magnesia is used to treat occasional constipation. The combination of magnesium hydroxide, aluminum hydroxide, and simethicone is recommended for heartburn, indigestion, or upset stomach. Acetaminophen is commonly taken as a pain reliever or to reduce fever.

Antiperspirant recalled due to contamination

• Suave 24-Hour Protection Aerosol Antiperspirant Powder (maker: Unilever)
• Suave 24-Hour Protection Aerosol Antiperspirant Fresh (maker: Unilever)

Comment: The maker of Suave antiperspirants is recalling these two products because testing revealed elevated levels of benzene.

Benzene is considered a carcinogen (a substance that can cause cancer). It can be absorbed through the skin, by inhalation, or through the mouth. Extensive exposure, including repeated exposure over time, can cause life-threatening leukemia, other cancers, and blood disorders. However, according to the FDA’s press release, the amount of benzene detected in these products would not be expected to cause health problems even with daily exposure.

Prescription medicines

Blood pressure medication recalled due to contaminant

• Accuretic (quinapril HCI/hydrochlorothiazide) tablets (maker: Pfizer)
• Greenstone generic quinapril HCl/hydrochlorothiazide tablets (maker: Pfizer)

Comment: Multiple lots of these brand name and generic medicines have been recalled due to the detection of a nitrosamine called N-nitroso-quinapril. Nitrosamines are commonly present at low levels in water and foods. However, exposure to high levels over time can potentially cause cancer.

Quinapril HCl/hydrochlorothiazide is prescribed to treat high blood pressure (hypertension) and prevent its complications, such as stroke or heart attack.

Injectable compounded medicines recalled due to unreliable dosing

• Olympia Pharmaceuticals B₁₂ vitamin (hydroxocobalamin) (distributor: Olympia Pharmacy)
• Olympia Pharmaceuticals Trimax Formulas F-9, T-105, and SB-4 (distributor: Olympia Pharmacy)
• Olympia Pharmaceuticals NAD+ (distributor: Olympia Pharmacy)
• Olympia Pharmaceuticals Sermorelin (hydroxocobalamin) (distributor: Olympia Pharmacy)
• Olympia Pharmaceuticals Sincalide (hydroxocobalamin) (distributor: Olympia Pharmacy)

Comment: A number of products from this maker were found to contain too much or too little of the labeled medicine. The recalled products include an injectable form of vitamin B₁₂, several injectable drugs for erectile dysfunction, an anti-aging supplement, a medicine used to test the function of the gallbladder and pancreas, and a medicine prescribed to evaluate and treat disorders of growth hormone production.

If the dose of medicine in the product is too low, its benefit may be less than expected. For example, a person who needs supplemental vitamin B₁₂ may experience nerve damage and vision loss if their dose of vitamin B₁₂ is too low. If the dose is higher than intended, it may cause serious side effects. For example, a higher than intended dose of certain drugs injected for erectile dysfunction may cause damage to the penis.

Syringe malfunction may prevent injection of epinephrine

• Adamis Pharmaceuticals epinephrine injection 0.15 mg (0.15 mg/0.3 mL) pre-filled single-dose syringes (maker: Adamis Pharmaceuticals Corporation)
• Adamis Pharmaceuticals epinephrine injection 0.3 mg (0.3 mg/0.3 mL) pre-filled single-dose syringes (maker: Adamis Pharmaceuticals Corporation)

Comment: Several batches of this product have been recalled because the needle may clog and prevent delivery of the medicine. Because epinephrine is taken for severe allergic reactions, failure to receive the medicine could lead to life-threatening complications, including breathing problems and low blood pressure.

Muscle relaxant recalled due to contamination

• Orphenadrine Citrate 100 mg extended release (ER) tablets (maker: Sandoz)

Comment: 13 lots of this medicine were recalled after testing revealed the presence of nitrosamine. Nitrosamines are commonly present at low levels in water and foods. However, exposure to high levels over time can potentially cause cancer.

Orphenadrine citrate is prescribed along with rest and physical therapy to treat short-term musculoskeletal pain, such as muscle strain or spasm.

Read additional issues of HHP Medication Safety Watch