HHP Medication Safety Watch: January 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

Rubbing alcohol may be contaminated with methanol (wood alcohol)

• Soho Fresh 70% Rubbing Alcohol (maker: Essaar, Inc.)

Comment: A single lot of this product was found to be contaminated with methanol. 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 develop from applying contaminated rubbing alcohol to the skin. Young children are at particular risk of accidental poisoning by these products. People with alcohol addiction and teens are also at high risk.

Oral rinse may be contaminated with bacteria

• GUM Paroex Chlorhexidine Gluconate Oral Rinse, 15 ml unit dose cups (maker: Precision Dose, Inc.)

Comment: Specific lots of this product may be contaminated with a bacterium called Burkholderia lata. Using this rinse could cause serious, or even life-threatening disease (such as pneumonia and blood infections), especially among people with a suppressed immune system.

This oral rinse is used to treat gum inflammation (gingivitis).

First ever countrywide alert issued for hand sanitizers from Mexico

Comment: The FDA has placed an import alert on all alcohol-based hand sanitizers from Mexico to prevent contaminated or poor quality sanitizers from being used by US consumers (see full press release here). This will allow the agency to review the products' safety more thoroughly than is routine before it can enter the US. This action follows hundreds of hand sanitizer recalls due to contamination with methanol (wood alcohol) or other deficiencies in the products. This is the FDA's first ever countrywide import alert for any type of drug product.

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 develop due to the topical application of contaminated hand sanitizer. Infants and young children are at particular risk of accidental poisoning by these products. People with alcohol addiction and teens are also at high risk.
 

Prescription medicines

Metformin may be contaminated with a carcinogen

• Metformin Hydrochloride, Extended-Release Tablets, 750 mg (maker: Nostrum Laboratories, Inc.)

Comment: Metformin is prescribed for type 2 diabetes. This action expands a recall in November 2020 to include an additional lot of this medicine. It has a higher than acceptable level of N-Nitrosodimethylamine (NDMA), which is classified as a probable carcinogen (a compound that may cause cancer).

In recent months, the FDA has issued recalls regarding more than 250 products containing metformin. See this link for the full list.
 

Read additional issues of HHP Medication Safety Watch