The products affected are 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX.
Pleo Homeopathic drug products are used as homeopathic drugs and have a label stating “Distributed by SANUM USA Corp.” The affected products were distributed nationwide through health care practitioners, who may have sold the products through websites.
The reason for the recall is because the U.S. Food and Drug Administration (FDA)
has determined that these products have the potential to contain penicillin or derivatives of penicillin, which may be produced during the fermentation process.
The risk,
MPR notes, is that in patients who are allergic to beta-lactam antibiotics, even at low levels, exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions.
