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HHP Medication Safety Watch: November 2020
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.
Nutritional supplement contains an unapproved food additive
- CORE Essential Nutrients (maker: Fusion Health and Vitality LLC)
Comment: All 2020 batches of this product have been voluntarily recalled by its maker after it was found to contain hordenine HCl, an unapproved and potentially unsafe food additive that may cause rapid heart rate and high blood pressure.
"Immune booster" is considered an unapproved new drug
- Immune Boost Sublingual Vitamin D3 (maker: Fusion Health and Vitality LLC)
Comment: All 2020 batches of this product have been voluntarily recalled after the FDA determined it to be an unapproved new drug. This determination was due to statements made on the drug's label.
Oral rinse may have bacterial contamination
- Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (maker: Loxha LLC)
Comment: Some batches of this product may be contaminated with a bacterium called Burkholderia lata. Use of the rinse could cause serious or even life-threatening infections (such as pneumonia), especially among those with a suppressed immune system. This oral rinse is used to treat gum inflammation (gingivitis).
Metformin may be contaminated with a compound that may cause cancer
- Metformin Hydrochloride, Extended-Release tablets, 500 mg (maker: Nostrum Laboratories, Inc.)
- Metformin Hydrochloride, Extended-Release tablets, 750 mg (maker: Nostrum Laboratories, Inc.)
Comment: Metformin is prescribed for type 2 diabetes. Some lots of this medicine contained a higher than acceptable level of N-Nitrosodimethylamine (NDMA), a known 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.
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