Infla-650 Herbal Dietary Supplements are being recalled because they contain three drugs that are not listed on the product label. The drugs are acetaminophen, diclofenac, and phenylbutazone. Any item that contains these products cannot be marketed as a dietary supplement. And the presence of these compounds means that the product is considered an unapproved drug for which safety and efficacy have not been established. No adverse reactions have been reported to the company to date. The recalling firm is Lilburn, GA, GURU INC.
This is the risk statement: “Risk Statement: Use of the product poses a serious threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. People who experience unintentional acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases. Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash, and blisters.
“Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products
“Phenylbutazone is a NSAID that was discontinued for human use in the United States due to the risk of serious and life-threatening injuries. The most serious and life-threatening injury associated with phenylbutazone treatment is bone marrow toxicity, which occurs when the body does not produce enough red blood cells, white blood cells, and/or platelets. Certain types of bone marrow toxicity are reversible; however, in rare circumstances it can lead to death. Patients with anemia, low white or red blood cell count, or decreased blood platelets may be at a greater risk of death or serious injury.”
The product is marketed as an herbal dietary supplement for pain relief. It is packaged in a stand up pouch of 60 capsules. The lot number is IN-032 and the expiration date is NOV 2027. It was shipped between March 3, 2024 to June 24, 2024 nationwide to retailers and it was also sold online.
If you bought this product do not take it. Throw it away in a secure trash can or take it back to the place of purchase for a full refund.
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