The Recall Desk
SevereFDA (Drugs)·D-1196-2014·Announced 2014-04-16

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

Terra-Medica Inc. is recalling Pleo Not Portable Sips oral homeopathic medicine due to 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 allergic reaction or serious injury to sensitive individuals.

Plain-English summary

Terra-Medica Inc. is recalling specific batches of Pleo Not Portable Sips, an oral homeopathic medicine available over-the-counter. The recall is being conducted because the products are subject to penicillin cross-contamination. The affected products include 10 x 1mL and 50 x 1mL cartons, which were manufactured in Germany by SANUM-Kehlbeck GmbH & Co. KG and distributed by SANUM USA Corp.

The recall covers 730 units of the 10 x 1mL cartons and 367 units of the 50 x 1mL cartons. These products were distributed nationwide in the United States, as well as to Canada, the Philippines, and through internet sales. Specific batch numbers and expiration dates are listed in the official recall notice, including batches expiring between August 2014 and January 2018.

Consumers who have purchased these products should stop using them and contact the recalling firm or their healthcare provider for further instructions. Individuals with a known allergy to penicillin should be particularly cautious and consult a medical professional if they have used the product.

The recalled product

Product
Pleo Not PORTABLE SIPS, 5X, 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: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 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 (13)

  • (10 x 1mL): Batch # 07099
  • EXP: August 2014
  • Batch # 15090
  • EXP: August 2015
  • Batch # 06120
  • EXP: November 2015
  • Batch #19023
  • EXP: January 2018. (50 x 1ml) Portable Sips: Batch # 07099
  • Batch # 1110
  • EXP: October 2015
  • Batch #6120
  • Batch # 19023
  • EXP January 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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