Fifty-six lots of various Pleo homeopathic drugs, which may contain undisclosed penicillin, have been recalled by Terra-Medica, Inc. Individuals allergic to penicillin could suffer reactions including life-threatening anaphylactic reactions.
The recalled products – used to treat conditions including colds, yeast infections, intestinal gas, and constipation – are Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX. Depending on the use, the products come in liquid, tablet, capsule, ointment, and suppository forms. The U.S. Food and Drug Administration (FDA) has determined that penicillin may have been produced during the fermentation process but is not listed on the products’ labels. Someone allergic to beta-lactam antibiotics could suffer an allergic reaction ranging from a mild rash to a life-threatening anaphylactic reaction with even a small exposure to penicillin.
The recall was announced yesterday on the FDA web site. A press release from Terra-Medica, which contains a complete list of recalled products and lot numbers, can be accessed at http://www.fda.gov/Safety/Recalls/ucm389832.htm. The Pleo products are labeled “Distributed by SANUM USA Corp,” and they were distributed nationwide through healthcare practitioners. The products may have been sold through practitioners’ web sites, the FDA notes.
Terra-Medica is notifying customers of the recall by letter and email. The company advises consumers to stop using the recalled products and return them to the point of purchase. Consumers with questions about the recall should contact Terra-Medica’s Customer Service Department at 888.415.0535, ext. 1, Monday through Friday from 8 a.m. to 5 p.m., Pacific Time.
The FDA encourages healthcare professionals and patients to report adverse events or side effects related to these products to the FDA MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.