The Recall Desk
SevereFDA (Drugs)·D-1200-2014·Announced 2014-04-16

Terra-Medica Recalls Pleo Quent Suppositories Due to Penicillin Contamination

Terra-Medica Inc. is recalling Pleo Quent Suppositories 3X 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. According to the rubric, an FDA Class II recall involving a significant hazard such as penicillin contamination, which poses a risk of serious allergic reactions, is categorized as Severe.

Plain-English summary

Terra-Medica Inc. is recalling Pleo Quent Suppositories 3X, an over-the-counter homeopathic medicine. The recall is being conducted because the product is subject to penicillin cross-contamination. The recalled product is identified by NDC 49807-2904-1 and includes Batch # 2089 with an expiration date of June 2014, and Batch #3031 with an expiration date of June 2016.

The affected product consists of 3725 cartons of 10 suppositories each. The product was manufactured in Germany by Sanum-Kehlbeck GmbH & Co. KG for SANUM USA Copr. Distribution occurred nationwide in the United States, as well as to Canada, the Philippines, and through internet sales.

Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for further instructions regarding the penicillin contamination.

The recalled product

Product
Pleo Quent SUPPOSITORIES 3X, 10 Suppository 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: 49807-2904-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — Homeopathic Medicine
Hazard
Affected units
3,725

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 # 2089
  • EXP: June 2014
  • Batch #3031
  • EXP: June 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 contamination

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