Food Poisoning Bulletin

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.

 

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
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Recall — Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Terra-Medica Issues Voluntary Nationwide Recall of Specified Lots of Pleo Homeopathic Drug Products Due to the Potential for Undeclared Penicillin

 

Contact:
Consumer:
1-888-415-0535
terry@biomedicine.com

FOR IMMEDIATE RELEASE – March 18, 2014 – 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. To date, Terra-Medica has not received any reports of adverse events related to this recall, nor any reports of product tests indicating penicillin content in the products.

The products are used as homeopathic drugs and have a label stating “Distributed by SANUM USA Corp.” The affected products are identified by package size, batch (lot) number and expiry date (ranging from March 2014 – May 2018) in the table accompanying this release. The batch number can be located at the side panel on the label. The affected products were distributed nationwide through health care practitioners, 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 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, or their health care practitioner that distributed the product. Consumers should contact their physician or healthcare provider if they have experienced reactions while taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to Terra Medica or the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Product Name Potency Pharmaceutical Form Package Size Batch # Expiry Date
PLEO-NOT 5X Portable sips 10 x 1ml 07099 08/2014
PLEO-NOT 5X Portable sips 10 x 1ml 15090 08/2015
PLEO-NOT 5X Portable sips 10 x 1ml 06120 11/2015
PLEO-NOT 5X Portable sips 10 x 1ml 19023 01/2018
PLEO-NOT 5X Portable sips 50 x 1ml 07099 08/2014
PLEO-NOT 5X Portable sips 50 x 1ml 15090 08/2014
PLEO-NOT 5X Portable sips 50 x 1ml 01110 10/2015
PLEO-NOT 5X Portable sips 50 x 1ml 06120 11/2015
PLEO-NOT 5X Portable sips 50 x 1ml 19023 01/2018
PLEO-NOT 6X Portable sips 10 x 1ml 25050 04/2015
PLEO-NOT 6X Portable sips 50 x 1ml 25050 04/2015
PLEO-NOT 7X Portable sips 10 x 1ml 20010 12/2014
PLEO-NOT 7X Portable sips 50 x 1ml 20010 12/2014
PLEO-NOT 5X Drops 10ml 21049 03/2014
PLEO-NOT 5X Drops 10ml 13059 04/2014
PLEO-NOT 5X Drops 10ml 09080 07/2015
PLEO-NOT 5X Drops 10ml 15100 09/2015
PLEO-NOT 5X Drops 10ml 24092 08/2017
PLEO-NOT 5X Tablets 20pcs 15070 06/2015
PLEO-NOT 5X Tablets 20pcs 24072 06/2017
PLEO-NOT 3X Ointment 30g 03051 04/2014
PLEO-NOT 3X Ointment 30g 13072 06/2015
PLEO-NOT 3X Ointment 30g 21033 04/2016
PLEO-NOT 3X Suppositories 10pcs 1080 07/2015
PLEO-NOT 3X Suppositories 10pcs 1102 09/2017
PLEO-NOT 4X Capsules 20pcs 14010 12/2014
PLEO-NOT 4X Capsules 20pcs 11080 08/2015
PLEO-NOT 4X Capsules 20pcs 12092 07/2017
PLEO-NOTA-QUENT 5X Drops 10ml 04062 05/2017
PLEO-NOTA-QUENT 5X Drops 10ml 06062 05/2017
PLEO-QUENT 5X Portable sips 10 x 1ml 13090 08/2015
PLEO-QUENT 5X Portable sips 50 x 1ml 13090 08/2015
PLEO-QUENT 5X Drops 10ml 15129 11/2014
PLEO-QUENT 5X Drops 10ml 12040 03/2015
PLEO-QUENT 5X Drops 10ml 01081 08/2016
PLEO-QUENT 4X Capsules 20pcs 25030 04/2015
PLEO-QUENT 4X Capsules 20pcs 27101 09/2016
PLEO-QUENT 3X Suppositories 10pcs 2089 06/2014
PLEO-QUENT 3X Suppositories 10pcs 3031 03/2016
PLEO-FORT 5X Portable sips 10 x 1ml 15030 02/2015
PLEO-FORT 5X Portable sips 10 x 1ml 12122 11/2017
PLEO-FORT 5X Portable sips 50 x 1ml 15030 02/2015
PLEO-FORT 5X Portable sips 50 x 1ml 12122 11/2017
PLEO-FORT 5X Drops 10ml 23109 09/2014
PLEO-FORT 5X Drops 10ml 08030 02/2015
PLEO-FORT 5X Drops 10ml 12032 02/2017
PLEO-FORT 5X Drops 10ml 26043 03/2018
PLEO-FORT 5X Tablets 20 pcs 27100 09/2015
PLEO-FORT 5X Tablets 20 pcs 29100 10/2015
PLEO-FORT 5X Tablets 20 pcs 25013 01/2018
PLEO-FORT 3X Suppositories 10pcs 3110 10/2015
PLEO-FORT 3X Suppositories 10pcs 1112 10/2017
PLEO-FORT 4X Capsules 20pcs 24030 02/2015
PLEO-FORT 4X Capsules 20pcs 14062 05/2017
PLEO-EX 5X Portable sips 10 x 1ml 09020 01/2015
PLEO-EX 5X Portable sips 10 x 1ml 03052 04/2017
PLEO-EX 5X Portable sips 50 x 1ml 09020 01/2015
PLEO-EX 5X Portable sips 50 x 1ml 03052 04/2017
PLEO-EX 5X Drops 10ml 07011 12/2015
PLEO-EX 5X Drops 10ml 09043 03/2018
PLEO-EX 3X Suppositories 10pcs 2011 12/2015
PLEO-EX 3X Suppositories 10pcs 2081 07/2016
PLEO-EX 3X Suppositories 10pcs 3063 05/2018
PLEO-EX 3X Suppositories 10pcs 1013 02/2018
PLEO-STOLO 6X Drops 10ml 08060 05/2015
PLEO-STOLO 6X Drops 10ml 07119 08/2014
PLEO-STOLO 6X Drops 10ml 03043 05/2018

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