Don’t Buy Antimicrobial Supplements, FDA Says

The U.S. Food and Drug Administration (FDA) is warning consumers not to use products marketed as <"">dietary supplements that also claim to be antimicrobial—antibiotic, antifungal, or antiviral—drugs. These illegal products are falsely promoted with claims to treat illnesses such as upper respiratory infections, sinusitis, pneumonia, bronchitis, and the common cold.

The FDA also announced that it has learned that several companies are distributing and promoting products labeled as dietary supplements for antimicrobial uses. These products may or may not contain antimicrobials, and their use could delay treatment for serious illnesses. The FDA noted that it determined that many of these products mimic the labeling of drugs available in Mexico and are marketed specifically to the Hispanic community.

Consumers should stop using these products immediately and contact their health care providers. Consumers using the products may believe they will receive the beneficial health effects of an antimicrobial drug. The products may or may not contain antimicrobials and are not FDA approved to treat, cure, or prevent medical conditions. Consumers may be using these products under the belief that they contain antimicrobials; doing so may cause worsening of existing illness and delayed treatment. An antimicrobial is a substance that kills or inhibits the growth of pathogens such as bacteria, viruses and fungi.

We previously wrote that the FDA is aware of at least four cases in Texas in which children received emergency care due to worsening illnesses after being given products that the parents may have believed contained antimicrobials. These products were packaged to resemble antimicrobial drugs readily available in Mexico. Some children were given, Amoxilina, which the parents may have believed was the antimicrobial Amoxicillin. Giving the product to the children delayed legitimate medical treatment.

All consumers are at risk. Although package labels are printed in English and Spanish, the packaging mimics antimicrobials readily available in Mexico and possibly familiar to Hispanic consumers. Consumers who have been using these types of products should consult their health care providers immediately. Consumers should be skeptical of any product that claims to be a dietary supplement and claims to treat, prevent, or cure disease or contain an antimicrobial.

Various companies market these products; the FDA is aware of the products below, but note that this list is probably not complete. These products were recalled May 6-12, 2011 and were distributed in Colorado, Delaware, Texas, Florida, California, Georgia, and potentially other markets. The products may be sold at various retailers, including small independent stores that cater to the Hispanic community.

Distributed by Multi-Mex:

• Amoxilina Capsules 500 Mg (30 Caps): UPC 619114010081

• Amoxilina Suspension (3.4 Oz): UPC 619114010074

• Pentreximil Plus 500 Mg (30 Caps): UPC 619114010012

• Pentreximil Plus Syrup 3.4 Oz: UPC: 619114010050

Distributed by Phoenix Import & Distribution:

• Pentrexyl Forte Natural, 30-capsule box containing capsules in blister packs: UPC 8 93843 00129 3

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