The Recall Desk
HighFDA (Drugs)·D-1209-2014·Announced 2014-04-16

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.

What this means for you

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
Hazard
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.

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Same hazard · allergen penicillin

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