Possible Penicillin Presence in Pleo Homeopathic Products

Terra-Medica 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 formulations. This recall is due to the potential for these products to contain penicillin or penicillin derivatives, which may have been produced during fermentation.

Penicillin exposure for those who are allergic to beta-lactam antibiotics can result in mild to severe reactions. Reactions can range from a mild rash to life-threatening anaphylactic reactions.

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These Pleo products are sold as homeopathic drugs and are indicated for various pain, respiratory, and digestive disorders. All affected products have an expiration date ranging from March 2014–May 2018 and the full list of batch (lot) numbers and package sizes can be found on the press release. Recalled products were distributed through healthcare providers who may have sold the products through websites.

Terra-Medica is notifying its customers by letter and email and is arranging for return of all affected products.

For more information call (888) 415-0535 or visit FDA.gov.

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