Terra-Medica Recalls Pleo Ex Drops Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Ex DROPS 5X homeopathic antifungal medicine due to penicillin cross-contamination. The product was distributed in the US, Canada, the Philippines, and online.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of allergic reaction from penicillin contamination.
Plain-English summary
Terra-Medica Inc. is recalling 3,440 bottles of Pleo Ex DROPS 5X, a 10 ml homeopathic antifungal medicine. The recall is due to penicillin cross-contamination. The product is an over-the-counter (OTC) medication made in Germany for SANUM USA Corp. by Sanum-Kehlbeck GMbH & Co. KG.
The affected product has NDC 49807-1003-1. Specific batches involved are Batch # 07011 with an expiration date of December 2015, and Batch # 09043 with an expiration date of March 2108. The products were distributed nationwide in the United States, to Canada, to the Philippines, and through internet sales.
Consumers should stop using the recalled product and contact Terra-Medica Inc. for further instructions or a refund. Individuals with a known penicillin allergy should exercise caution and consult a healthcare provider if they have used the product.
The recalled product
- Product
- Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.
- Manufacturer
- Terra-Medica Inc.
- Category
- Drug — Homeopathic Medicine
- Affected units
- 3,440
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 (4)
- Batch # 07011
- EXP: December 2015
- Batch # 09043
- EXP: March 2108.
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
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