The Recall Desk
SevereFDA (Drugs)·D-1207-2014·Announced 2014-04-16

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

Terra-Medica Inc. is recalling Pleo-Fort DROPS 5X homeopathic medicine due to penicillin cross-contamination. The product was 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, which corresponds to a 'Severe' severity score under the rubric, particularly given the risk of penicillin cross-contamination.

Plain-English summary

Terra-Medica Inc. is recalling 8,405 bottles of Pleo-Fort DROPS 5X, a 10ml homeopathic digestive aid medicine. The recall is being conducted because the product is subject to penicillin cross-contamination. The product is an over-the-counter (OTC) medication made in Germany for SANUM USA Copr by Sanum-Kehlbeck GmbH & Co. KG.

The affected product includes bottles with the following batch numbers and expiration dates: Batch # 23109 (EXP: September 2014), Batch # 08030 (EXP: February 2015), Batch # 12032 (EXP: February 2017), and Batch # 26043 (EXP: March 2018). The NDC for the product is 49807-1101-1.

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. Consumers should check their home medicine cabinets for this product and stop using it if they have it.

The recalled product

Product
Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — Homeopathic Medicine
Hazard
Affected units
8,405

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 (8)

  • Batch # 23109
  • EXP: September 2014
  • Batch # 08030
  • EXP: February 2015
  • Batch # 12032
  • EXP: February 2017
  • Batch # 26043
  • EXP: March 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 cross contamination

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