FDA Recalls Herbal Product Containing “Serious and Life-Threatening” Components

(PatriotPostNews.com) — The US Food and Drug Administration (FDA) issued a nationwide recall for a commonly used herbal supplement. The FDA said that the herbal product had ingredients that posed a “serious threat.”

The supplement is called Infla-650 and was produced by GURU Inc. Infla-650 was discovered to contain unlisted and potentially toxic ingredients, including a drug discontinued for human use in 1982. Infla-650 is made from a variety of herbs based on ancient Indian folk medicine and is billed as a natural pain relief aid. GURU Inc voluntarily recalled the affected products after the discovery was made.

Even drugs known to be safe can cause injury or death when not labeled. Acetaminophen was found in the supplement. Acetaminophen is safe in small doses as a painkiller, but because it was unlabeled, an individual could unknowingly overdose on Acetaminophen. Diclofenac was also found in Infla-650. Diclofenac is prescription non-steroidal anti-inflammatory drug (NSAID) that is known to cause gastrointestinal as well as cardiovascular injuries in humans in high doses. Again, without being labeled, consumers cannot know how much of the drug they are taking and risk serious side effects.

The third drug illegally found in the supplement was Phenylbutazone. Phenylbutazone is also a NSAID, but it was found to pose too high of a risk for human use. The drug can cause bone marrow toxicity, which can easily become fatal. Even with the risks, Phenylbutazone is still found in illicit street drugs.

In a statement, the FDA warned consumers that supplements generally do not undergo the same scrutiny as standard medications. The FDA said that supplements are often classified as “unproven.” The FDA cannot guarantee the effectiveness or safety of “unproven” drugs. The FDA ended the statement and urged customers to “exercise extreme caution.” The FDA and GURU INC have ordered customers to discontinue use of the supplement; there have been no reported injuries or other unwanted effects of the supplement.