A Georgia company accused of marketing dietary supplements as antibiotics announced a recall Monday days after the Texas Attorney General slapped the company with a temporary restraining order prohibiting sales of the pills in his state.
Multi-Mex Distributor Inc. of Tucker, Georgia, the Food and Drug Administration announced, is recalling a number of dietary supplements sold in the following states: California, Colorado, Georgia, Illinois, North Carolina, South Carolina, Tennessee and Texas, and in Indianapolis.The supplements are marketed under a number of names, most notably Amoxilina (for a full list of the recalled products, click here). Despite both English and Spanish labels, the FDA says the recall was initiated after an inspection revealed "the packaging appears to be an intentional marketing ploy to mimic antibiotics and directed at Hispanic buyers."
Four children in Texas were taken to the hospital for worsening illnesses after their parents gave them Amoxilina, which they mistakenly believed was a popular over-the-counter antibiotic sold in Mexico under the name Amoxicillin, delaying effective medical treatment.
Texas Attorney General Greg Abbott announced the temporary restraining order on May 6 against Multimex and Houston-based San Martin Distributing Inc. for illegally marketing dietary supplements. Both companies are prohibited from distributing Amoxilina in Texas and are being charged with violation of the state's Deceptive Trade Practices Act (DTPA).
The attorney general's lawsuit accuses the defendants of marketing Amoxilina to Hispanic families in an illegal attempt to trick them into believing they were actually buying the Mexican antibiotic Amoxicillin.
"The defendants are charged with defrauding their customers -- and unnecessarily putting Texas children at risk," Attorney General Abbott said in a statement. "From the product's name to its packaging, there was a clear attempt to confuse Texas families and mislead purchasers into thinking they were buying antibiotics."
The deceitful marketing of Amoxilina, the lawsuit charges, included a two-toned, blue and white box that mimics the packaging of Amoxicillin -- right down to the red letters used to display the product's 500 mg strength.
The lawsuit also notes that Amoxilina labels claim -- in both Spanish and English -- that the dietary supplement is "without side effects and Naturally Combats Infection." And the back of each capsule's membrane contains the following Spanish phrase: "Cualidades Antibioticas Naturales," which means "Quality Natural Antibiotics."
Spanish-speaking parents complained to the attorney general's office that they had mistakenly purchased Amoxilina to treat children suffering from throat or ear infections because they believed they were buying Amoxicillin, claims echoed by a physician's affidavit.
Giving children Amoxilina, the attorney general's office noted, might lead doctors to improperly evaluate and treat the children or conduct unnecessary medical procedures.
The FDA urges consumers who purchased any of the recalled products to return them to the place of purchase for a full refund. Retail stores and distributors should return the products to Multi-Mex, 4744-C North Royal Atlanta Drive, Tucker, Georgia, 30084. Consumers with questions may call at (678) 226-1758 (Monday-Friday 9:00 am – 5:00 pm EST).
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