Infla-650 Infla-650 Herbal Dietary Supplement Capsules recall: Tainted with the drug ingredients: acetaminophen

What the company announced

FOR IMMEDIATE RELEASE – 07/16/2024 – Lilburn, GA, 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.

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.

GURU INC has not received any reports of adverse events to date related to this 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 internet via https://www.nutraherbusa.com/ and https://www.nutra650.com/ .

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.

Consumers with questions regarding this recall can contact GURU INC. on (470) 536 9800 or [email protected] Monday to Friday, 9:00 AM to 5:00 PM Eastern Time (ET). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.