FDA orders recall of homeopathic “medicine” due to potential penicillin contamination!
ISSUE: Terra-Medica, Inc. is voluntarily recalling 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms to the consumer level. FDA has determined that these products have the potential to contain penicillin or derivatives of penicillin, which may be produced during the fermentation process. 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. See the press release for a complete listing of products affected by this recall.
BACKGROUND: 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.