FDA Issues Intestinomicina Warning: Contains Recalled Chloraphenicol

Federal health regulators are warning that an over-the-counter diarrhea medication contains a recalled drug that has been linked to severe and potentially life-threatening health complications. 

The FDA issued an Intestinomicina safety warning on September 18, indicating that consumers should immediately stop using the diarrhea drug and see a health care provider, as the product contains chloramphenicol, which was recalled in July because it was found to be toxic to bone marrow.

Intestinomicina is manufactured in El Salvador, and distributed by South and Central American specialty food stores. It is sold in a rectangular yellow box labeled with the product name in red lettering. The labels are written in Spanish. It lists “chloramfenicol palmitato” as an active ingredient.

Chloramphenicol has been linked to serious and life-threatening injuries due to bone marrow toxicity, which can halt the production of red blood cells, white blood cells and platelets. Consumers with anemia may be at a greater risk of injury or death due to a rapid decrease in blood cell count.

Intestinomicina also includes the antibacterial ingredient neomycin, which is contained in medications that are sometimes labeled as sulfa drugs. Ingestion of neomycin and other sulfa drugs can potentially cause adverse effects such as rashes, hives, and sometimes severe and life threatening injuries.

The FDA has strongly advised that anyone who has taken this product should stop immediately and consult with a health care provider. Health care professionals and consumers are encouraged to report any adverse events related to Intestinomicina to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.