GURU Inc. is recalling Infla-650 Herbal Dietary Supplement Capsules, Lot No. IN-032, 700 mg to the consumer/user level.
The U.S. Food and Drug Administration (FDA) reports 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 FDA warns that 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.
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.
What to do
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 the place of purchase.
Consumers with questions regarding this recall can contact GURU Inc. at (470) 536 9800 or info@nutraherbusa.com 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.
