The Recall Desk
SevereFDA (Drugs)·D-1204-2014·Announced 2014-04-16

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

Terra-Medica Inc. is recalling Pleo Fort Suppositories because of 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 allergic reaction from penicillin contamination.

Plain-English summary

Terra-Medica Inc. is recalling Pleo Fort Suppositories, a homeopathic digestive aid medicine, due to penicillin cross-contamination. The recalled product is identified by NDC 49807-1106-1 and is sold in 10-suppository cartons. The manufacturer is Sanum-Kehlbeck GmbH & Co. KG, and the product is made in Germany for SANUM USA Copr.

The recall involves 2,147 cartons of the product. Specific batches affected include Batch # 3110 with an expiration date of October 2015, and Batch # 1112 with an expiration date of October 2017. The products were distributed nationwide in the United States, as well as to Canada and the Philippines, and were also sold through the internet.

Consumers who have purchased this product should stop using it and contact Terra-Medica Inc. for further instructions or a refund. Individuals with a known allergy to penicillin should be particularly cautious, as the presence of penicillin cross-contamination poses a risk of allergic reaction.

The recalled product

Product
Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, 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: 49807-1106-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — OTC Homeopathic
Hazard
Affected units
2,147

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 # 3110
  • EXP: October 2015
  • Batch # 1112
  • EXP: October 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 →

Related recalls

Same manufacturer · Terra-Medica Inc.

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Same hazard · penicillin contamination

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