The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1205-2014·Announced 2014-04-16

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

Terra-Medica Inc. is recalling Pleo Fort Capsules 4X due to penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a high-risk allergen (penicillin) cross-contamination in a drug product. Per the rubric, high-risk hazards without reported illness are classified as High (Score 3).

Plain-English summary

Terra-Medica Inc. is recalling 4,050 cartons of Pleo Fort CAPSULES 4X, a homeopathic digestive aid medicine. The recall is being conducted because the product is subject to penicillin cross contamination. The affected product is identified by NDC 49807-1103-1 and includes Batch # 24030 with an expiration date of February 2015, and Batch # 14062 with an expiration date of May 2017.

The recalled product was distributed nationwide in the United States, as well as to Canada and the Philippines, and was also sold through the internet. The product was made in Germany for SANUM USA Copr by Sanum-Kehlbeck GmbH & Co. KG.

Consumers who have this product should stop using it and contact Terra-Medica Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Pleo Fort CAPSULES 4X, 20 Capsule Cartons 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: 49807-1103-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — OTC Homeopathic
Hazard
Affected units
4,050

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 (4)

  • Batch # 24030
  • EXP: February 2015
  • Batch # 14062
  • EXP: May 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 →

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