The Recall Desk
SevereFDA (Drugs)·D-1212-2014·Announced 2014-04-16

Terra-Medica Recalls Pleo Stolo Drops Due to Penicillin Cross Contamination

Terra-Medica Inc. is recalling specific batches of Pleo Stolo DROPS 6X homeopathic medicine due to penicillin cross-contamination. Consumers should stop using the product and contact the company for a refund.

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 and involves penicillin cross-contamination, which poses a significant risk of allergic reaction or hospitalization for sensitive individuals, meeting the criteria for a Severe rating.

Plain-English summary

Terra-Medica Inc. is recalling 428 bottles of Pleo Stolo DROPS 6X, 10ml Bottle, a homeopathic anti-inflammatory medicine. The recall is being conducted because the product was found to have penicillin cross-contamination. The affected product is identified by NDC 49807-0011-1 and includes Batch # 08060 (EXP: May 2015), Batch # 07119 (EXP: August 2014), and Batch # 03043 (EXP: May 2018).

The product was distributed nationwide in the United States, as well as to Canada, the Philippines, and through internet sales. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased this product should stop using it immediately. They should contact Terra-Medica Inc. for a refund or further instructions. Individuals with a known allergy to penicillin should be particularly cautious and consult a healthcare professional if they have used the product.

The recalled product

Product
Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — Homeopathic Medicine
Hazard
Affected units
428

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 (6)

  • Batch # 08060
  • EXP: May 2015
  • Batch # 07119
  • EXP: August 2014
  • Batch # 03043
  • EXP: May 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 · penicillin contamination

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