The Food and Drug Administration has announced a recall of Infla-650 Herbal Dietary Supplement Capsules which were marketed for pain relief.
The capsules were tainted with acetaminophen, diclofenac and phenylbutazone, none of which are listed on the supplement’s label.
If the ingredients are included in a product, it cannot be marketed as a dietary supplement, the FDA said.
The agency also said that the supplement has not been approved as a “new drug for which safety and efficacy have not been established and, therefore, subject to recall.”
The FDA said that by taking the supplements, users can risk an intentional acetaminophen overdose which could cause liver damage.
Diclofenac is a non-steroidal anti-inflammatory drug or NSAID. Use of NSAIDs can cause a higher risk of cardiovascular events, and gastrointestinal damage and can interact with other medications.
Phenylbutazone is a discontinued NSAID that can cause bone marrow toxicity. It is not cleared for use in humans.
The recalled Infla-650 Herbal Dietary Supplement Capsules were sold with Lot No. IN-032 and expiration date of Nov. 2027. It has a silver standup pouch that contains 60 capsules. It was shipped nationwide from March 4 to June 24 to retailers and via nutraherbusa.com and nutra650.com
If you have the supplements, you’re being told not to use them and return to the place of purchase, the FDA said.
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