Intestinomicina Contains Chloramphenicol Ingredient Withdrawn from US Market

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Healthcare professionals and consumers are warned by the FDA not to use Intestinomicina, by Laboratorios Lopez, because it contains the ingredient chloramphenicol that has been withdrawn from the US market in July 2012 due to the risk of severe adverse events or death.

Background of Intestinomicina

Intestinomicina, by Laboratorios Lopez, is marketed as a treatment for acute gastrointestinal infections and infectious diarrhea. It is manufactured in El Salvador.

The product is found in tablet and liquid forms and it has been located in international grocery stores in the US providing South and Central American specialty foods and products.

FDA Alert on Intestinomicina

The FDA warns that Intestinomicina should not be consumed as it contains chloramphenicol which can cause severe adverse events or death. Bone marrow toxicity that has been associated with chloramphenicol, in rare cases can lead to death.

In addition, the product label ingredients include Neomycin and Sulfonamides. These ingredients may also lead to severe and life-threatening health consequences.

Recommendation on Intestinomicina

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

Contacting the FDA to report cases with Intestinomicina

In case of detection of adverse events or side effects related to the use of Intestinomicina, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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