GURU INC. is issuing a voluntary recall of Infla-650 Herbal Dietary Supplement Capsules, Lot No. IN-032, 700 mg to the consumer level. These capsules have been found to be tainted with acetaminophen, diclofenac, and phenylbutazone, none of which are listed on the label. Products containing these substances cannot be marketed as dietary supplements. Consequently, Infla-650 is classified as an unapproved new drug, and its safety and efficacy have not been established. Using this product poses a significant threat to consumers. The presence of acetaminophen can result in unintentional overdose, particularly when combined with other acetaminophen-containing products. Overdose can cause severe liver damage (hepatotoxicity), ranging from liver function abnormalities to acute liver failure and even death.
Symptoms of liver damage can take several days to appear, which may delay seeking prompt medical attention. Additionally, acetaminophen can cause serious skin reactions, including reddening, rash, and blisters. Diclofenac, a non-steroidal anti-inflammatory drug (NSAID), can increase the risk of cardiovascular events such as heart attacks and strokes, and can cause serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. The hidden presence of this drug may also interact with other medications, increasing the risk of adverse events, especially when multiple NSAID-containing products are used.
Phenylbutazone, another NSAID, was discontinued for human use in the United States due to its risk of serious and life-threatening injuries. The most serious risk associated with phenylbutazone is bone marrow toxicity, which can prevent the production of red blood cells, white blood cells, and platelets. This condition can sometimes be reversible but can also be fatal in rare cases. Patients with preexisting conditions such as anemia, low blood cell counts, or decreased platelets are at higher risk of death or serious injury.
Product Details and Distribution
The recalled product is marketed as an herbal dietary supplement for pain relief and is packaged in 60-capsule stand-up pouches. The affected lot, IN-032, has an expiration date of November 2027. The product can be identified by a silver stand-up pouch with a green and white color-themed label. Infla-650 was distributed nationwide to retailers and online via NutraHerbUSA.com and Nutra650.com from March 4, 2024, to June 24, 2024.
GURU INC. is notifying its distributors and customers via email and is arranging for the return of all recalled products. Consumers and retailers in possession of the recalled Infla-650 capsules should stop using them immediately and return them to the place of purchase. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to using this product.
Reporting Adverse Reactions
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. To report online, visit the FDA MedWatch website. For regular mail or fax, download the form or call 1-800-332-1088 to request a reporting form, then complete and return it 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.
GURU INC. is a company committed to developing and distributing high-quality herbal dietary supplements. The company values consumer safety and transparency, ensuring that all products meet regulatory standards and provide accurate labeling. GURU INC. Actual results may differ materially and adversely from current expectations based on various risks, uncertainties, and factors, including those related to the recall and any future recalls, potential adverse events, and regulatory actions by the FDA. GURU INC. assumes no obligation to publicly update any forward-looking statements, whether due to new information, future developments, or otherwise, except as required by applicable securities laws.
Resource: U.S. Food and Drug Administration, July 16, 2024
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