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HHP Medication Safety Watch: August 2021

September 7, 2021

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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

Weight-loss supplement recalled due to contamination with sibutramine

Comment: This dietary supplement marketed for weight loss has been recalled due to contamination with sibutramine.

Sibutramine was approved by the FDA in 1997 as a weight loss drug, then withdrawn from the market in 2010 because it increased the risk of stroke and heart attack. Side effects of sibutramine include increased blood pressure and heart rate, shortness of breath, and chest pain, especially among people with previous heart disease or stroke.


Prescription medicines

Some lots of atovaquone recalled due to problems with temperature control during shipping
  • KVK Tech atovaquone oral suspension,750 mg/5 ml (maker: KVK Tech, Inc.)

Comment: Two lots of this product were voluntarily recalled after customer complaints that it seemed gritty. The makers determined that these lots were exposed to extreme cold during shipping. This can alter the medication’s stability, consistency, taste, and effectiveness.

Atovaquone is an antimicrobial drug prescribed to prevent or treat Pneumocystis jiroveci, a type of pneumonia that most commonly affects people with immune deficiency, including HIV.

Some lots of Chantix recalled due to higher than acceptable levels of a cancer-causing contaminant
  • Chantix, certain lots of 0.5 mg and 1 mg tablets and certain Chantix kits containing 0.5 mg/1 mg tablets (maker: Pfizer)

Comment: This recall of four lots of the smoking cessation drug Chantix expands an earlier recall from July 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, they may cause cancer if exposure is higher than acceptable levels over the long term.


Read additional issues of HHP Medication Safety Watch

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