The Recall Desk
HighFDA (Drugs)·D-1198-2014·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 due to penicillin cross-contamination.

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 is classified as FDA Class II, and the hazard involves penicillin cross-contamination, which poses a significant risk of allergic reaction to sensitive individuals, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Terra-Medica Inc. is recalling specific batches of Pleo Not Portable Sips 7X, an oral homeopathic medicine. The recall involves 10 x 1 mL and 50 x 1 mL cartons with Batch # 20010 and an expiration date of December 2014. The product is manufactured by Sanum-Kehlbeck GmbH & Co. KG in Germany and distributed by SANUM USA Corp.

The recall was initiated due to penicillin cross-contamination. The affected products were distributed nationwide in the United States, as well as to Canada and the Philippines, and through internet sales. The total quantity recalled is 32 cartons of the 10 x 1 mL size and 14 cartons of the 50 x 1 mL size.

Consumers who have purchased these specific batches should stop using the product 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 professional if they have used the product.

The recalled product

Product
Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic 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: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL 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 1 mL) Portable Sips: Batch # 20010
  • EXP: December 2014. (50 x 1ml) Portable Sips: Batch # 20010
  • EXP: December 2014.

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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