The Recall Desk
SevereFDA (Drugs)·D-1201-2014·Announced 2014-04-16

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

Terra-Medica Inc. is recalling Pleo Quent capsules 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (such as penicillin cross-contamination) are rated as Severe (4).

Plain-English summary

Terra-Medica Inc. is recalling 3,066 cartons of Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine. The recall is due to penicillin cross-contamination. The product is an over-the-counter homeopathic medicine made in Germany for SANUM USA Copr by Sanum-Kehlbeck GmbH & Co. KG.

The affected products include Batch # 25030 with an expiration date of April 2015 and Batch # 27101 with an expiration date of September 2016. The NDC number is 49807-2902-1. The products were distributed nationwide in the United States, to Canada, to the Philippines, and through internet sales.

Consumers should stop using the recalled product and contact their healthcare provider if they have concerns about penicillin allergy or exposure. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Pleo Quent CAPSULES 4X, 20 Capsule Cartons, 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: 49807-2902-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — Homeopathic Medicine
Hazard
Affected units
3,066

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 # 25030
  • EXP: April 2015
  • Batch # 27101
  • EXP: Sept 2016.

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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