Terra-Medica is recalling 56 lots of homoepathic drug products because they may have the drug penicillin that is not declared on the label. Anyone who is allergic to penicillin, or allergic to beta-lactam antibiotics, even at low levels, could have a serious or life-threatening anaphylactic reaction if they consume these products. The penicillin or derivatives of penicillin could be produced during the fermentation process. No reports of adverse reactions have been reported to date.
The recalled products are Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products, in liquid, tablet, capsules, ointment, and suppository forms. The products have a label stating “Distributed by SANUM USA Corp.” The expiration dates range from March 2014 through May 2018. You can see the long list of batch numbers and types at the FDA web site.
If you purchased these products and are allergic to penicillin or beta-lactam antibiotics, do not consume them. Return to the place of purchase or discard. You can report adverse reactions to the FDA’s MedWatch Adverse Event Reporting program. Terra-Medica is notifying customers by letter and email.
