The Recall Desk
SevereFDA (Drugs)·D-1206-2014·Announced 2014-04-16

Terra-Medica Recalls Pleo Fort Portable Sips Due to Penicillin Contamination

Terra-Medica Inc. is recalling Pleo Fort Portable Sips homeopathic medicine because of penicillin cross-contamination. The products were distributed in the US, Canada, and the Philippines.

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 hazard involves penicillin cross-contamination, which poses a significant risk of severe allergic reactions or anaphylaxis to susceptible individuals, meeting the criteria for a Severe rating.

Plain-English summary

Terra-Medica Inc. is recalling specific cartons of Pleo Fort Portable Sips 5X, an oral homeopathic medicine. The recall is being conducted due to penicillin cross-contamination. The affected products include 10 x 1 mL and 50 x 1 mL cartons manufactured in Germany for SANUM USA Corp.

The recalled products were distributed nationwide in the United States, as well as to Canada and the Philippines, and were also sold through the internet. The specific batches involved are #15030 (expiration February 2015) and #12122 (expiration November 2017). The total quantity recalled is 126 of the 10 x 1 mL cartons and 76 of the 50 x 1 mL cartons.

Consumers who have purchased these specific products should stop using them and contact the recalling firm or their healthcare provider for further instructions. Individuals with a known penicillin allergy should be particularly cautious and consult a medical professional regarding any exposure.

The recalled product

Product
Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Me
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 (5)

  • 10 x 1 ml Cartons: Batch # 15030
  • EXP: February 2015
  • Batch # 12122
  • EXP: November 2017. 50 x 1 ml: Batch # 15030
  • EXP: November 2017.

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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