Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin
Audience: Consumer
Includes Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX
[Posted 03/20/2014]
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.
RECOMMENDATION: Terra-Medica is notifying its customers by letter and email and is arranging for return of all recalled products. Consumers and distributors that have product which is subject to the recall should stop using the products and return them to the point of purchase. Consumers with questions regarding this recall can contact Terra-Medica’s Customer Service Department at (888) 415-0535, ext. 1, Monday through Friday between 8-5pm, Pacific Time Zone.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[03/20/2014 - Press Release - Terra-Medica]
[03/20/2014 - Product Photos - FDA]
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