Safety Report: Infla-650 Herbal Dietary Supplement Capsules - recalled due to undeclared drug ingredients, USA

United States

GURU INC. is voluntarily recalling Infla-650 Herbal Dietary Supplement Capsules, Lot No. IN-032, 700 mg to the consumer/user level. Infla-650 capsules has been found to be tainted with acetaminophen, diclofenac and phenylbutazone, which are not listed on the label. Products containing acetaminophen, diclofenac and phenylbutazone cannot be marketed as dietary supplements. Infla-650 Herbal Dietary Supplement Capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

The tainted product is marketed as an herbal dietary supplement for pain relief and is packaged in stand-up pouches of 60 capsules. The affected Infla-650 product, include the following Lot No. IN-032 and expiration date: NOV. 2027. The product can be identified by silver standup pouch with green in white color theme label. Infla-650 was shipped between 03/04/2024-06/24/2024 nationwide to retailers and on the internet

GURU INC. is notifying its distributors and customers by email and is arranging for the return of all recalled products. Consumers and retailers that have Infla-650 which is being recalled should stop using/return to place of purchase.

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.

In case you experienced harm from undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Consumers with questions regarding this recall can contact GURU INC. on (470) 536 9800 Monday to Friday, 9:00 AM to 5:00 PM Eastern Time (ET).

Company name: Guru Inc.
Brand name: Infla-650
Product recalled: Infla-650 Herbal Dietary Supplement Capsules
Reason of the recall: Tainted with the drug ingredients: acetaminophen, diclofenac and phenylbutazone
FDA Recall date: July 16, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/guru-inc-issues-voluntary-nationwide-recall-infla-650-herbal-dietary-supplement-capsules-due-hidden