The Recall Desk
SevereFDA (Drugs)·D-1197-2014·Announced 2014-04-16

Terra-Medica Recalls Pleo Not Portable Sips Due to Penicillin Contamination

Terra-Medica Inc. is recalling specific batches of Pleo Not Portable Sips oral homeopathic medicine because of penicillin cross-contamination.

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 the source explicitly identifies penicillin cross-contamination, which is a significant hazard for allergic individuals.

Plain-English summary

Terra-Medica Inc. is recalling 55 cartons of Pleo Not Portable Sips, 6X, 10 x 1mL and 51 cartons of Pleo Not Portable Sips, 6X, 50 x 1mL. The affected products are oral homeopathic medicines made in Germany and distributed by SANUM USA Corp. The specific batch number for both product sizes is 25050, with an expiration date of April 2015.

The recall was initiated due to penicillin cross-contamination. This hazard poses a risk to individuals with penicillin allergies. The products were distributed nationwide in the United States, as well as to Canada, the Philippines, and through internet sales.

Consumers who have purchased these specific batches should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Ca
Manufacturer
Terra-Medica Inc.
Category
Drug — Homeopathic Medicine
Hazard

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 (3)

  • (10 x 1mL) Batch # 25050
  • EXP: April 2015. (50 x 1mL): Batch # 25050
  • EXP: April 2015.

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 →

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Same manufacturer · Terra-Medica Inc.

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Same hazard · penicillin contamination

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