Terra-Medica Recalls Pleo Ex Suppositories Due to Penicillin Cross-Contamination
Terra-Medica Inc. is recalling Pleo Ex Suppositories because of penicillin cross-contamination. The affected homeopathic antifungal products were distributed in the US, Canada, and the Philippines.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk allergen (penicillin) cross-contamination in a drug product. While the agency classification is Class II, the specific hazard of allergen contamination in a medication aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terra-Medica Inc. is recalling Pleo Ex SUPPOSITORIES 3X, a homeopathic antifungal medicine, due to penicillin cross-contamination. The recalled product is an over-the-counter suppository manufactured in Germany by Sanum-Kehlbeck GmbH & Co. KG and distributed by SANUM USA Corp. The recall involves 5,940 packages of the product.
The affected products were distributed nationwide in the United States, as well as to Canada, the Philippines, and through internet sales. The recall covers specific batches with expiration dates ranging from December 2015 to May 2018. The presence of penicillin cross-contamination poses a risk to individuals with penicillin allergies.
Consumers who have purchased these products should stop using them immediately and contact the distributor or retailer for a refund or replacement. Individuals with a known penicillin allergy should be particularly cautious and consult a healthcare provider if they have used the product.
The recalled product
- Product
- Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1.
- Manufacturer
- Terra-Medica Inc.
- Category
- Drug — Homeopathic Medicine
- Affected units
- 5,940
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Batch # 2011
- EXP: December 2015
- Batch # 2081
- EXP: July 2016
- Batch # 3063
- EXP: May 2018
- Batch # 1013
- EXP: February 2018.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Terra-Medica Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
Same manufacturer · Terra-Medica Inc.
See all →- SevereTerra-Medica Recalls Pleo Not Ointment Due to Penicillin Cross Contamination
FDA (Drugs) · 2014-04-16
- SevereTerra-Medica Recalls Pleo Nota-Quent Drops Due to Penicillin Contamination
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- SevereTerra-Medica Recalls Pleo Fort Portable Sips Due to Penicillin Contamination
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- SevereTerra-Medica Recalls Pleo Not Portable Sips Due to Penicillin Contamination
FDA (Drugs) · 2014-04-16
- SevereTerra-Medica Recalls Pleo Quent Drops Due to Penicillin Cross Contamination
FDA (Drugs) · 2014-04-16
Same hazard · allergen penicillin
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- HighLife Science Pharmacy Recalls TRI-EST Gels Due to Penicillin Contamination
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- HighLife Science Pharmacy Recalls Compounded Estriol Suppositories Due to Penicillin Contamination
FDA (Drugs) · 2015-12-09
- HighLife Science Pharmacy Recalls Compounded Estriol Vaginal Creams
FDA (Drugs) · 2015-12-09
- HighLife Science Pharmacy Recalls Compounded Estriol Gels Due to Penicillin Contamination
FDA (Drugs) · 2015-12-09
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