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Posted September 18, 2012

Consumers Warned Not To Use Gastrointestinal Product Containing Withdrawn Prescription Drug

On September 18, 2012, the FDA issued a warning to consumers not to use Intestinomicina, a drug product marketed for the treatment of infectious diarrhea and acute gastrointestinal infections. Intestinomicina contains Chloramphenicol, a prescription drug withdrawn from the United States market in July 2012 due to the potential for serious and life-threatening injuries, including bone marrow toxicity.

The product also contains Neomycin, an antibiotic found in topical medications, and Sulfonamides. Both drugs have the potential to cause adverse effects, including rashes, hives, and life-threatening allergic reactions.

Consumers who have purchased this product should stop taking it immediately and consult with a health care provider.

Intestinomicina is manufactured by Laboratorios Lopez in El Salvador but available in the U.S. in international and specialty grocery stores. It is available in tablet and liquid forms and may be labeled in Spanish or in English.

Healthcare professionals and patients should report adverse events related to the use of Intestinomicina to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.