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HHP Medication Safety Watch: September 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.
Medicine for rare neurologic condition recalled due to contamination
- Amifampridine (brand name: Ruzurgi), 10 mg tablets (maker: Jacobus Pharmaceutical Company Inc.)
Comment: Several lots of this medicine were recalled after tests revealed contamination with yeast, mold, and bacteria. People taking this contaminated medicine could develop a serious or even fatal infection. The risk may be higher among people who are immunocompromised, including people with Lambert Eaton syndrome, the condition for which this medicine is taken. (Lambert Eaton syndrome is a rare disease that causes muscle weakness. It occurs most often in people with cancer or autoimmune disease.)
Chantix recalled due to higher than acceptable levels of a cancer-causing contaminant
- Chantix, all lots of 0.5 mg and 1 mg tablets (maker: Pfizer)
Comment: This recall of the smoking cessation drug Chantix expands earlier recalls in July and August 2021. The action was taken due to higher than acceptable levels of N-nitroso-varenicline, a type of nitrosamine. Though nitrosamines are found in water and many foods, long-term exposure to higher than acceptable levels may cause cancer.
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No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.
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