The Recall Desk
SevereFDA (Drugs)·D-1192-2014·Announced 2014-04-16

Terra-Medica Recalls Pleo Not Suppositories Due to Penicillin Cross Contamination

Terra-Medica Inc. is recalling Pleo Not Suppositories 3X due to penicillin cross-contamination. The affected homeopathic medicine 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. Under the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant hazards like penicillin cross-contamination which poses a risk of allergic reaction.

Plain-English summary

Terra-Medica Inc. is recalling Pleo Not Suppositories 3X, a homeopathic over-the-counter medicine, due to penicillin cross-contamination. The product is manufactured by SANUM-Kehlbeck GmbH & Co. KG in Germany and distributed by SANUM USA Corp. The recall involves 4,860 cartons of the 10-suppository size.

The affected products include Batch # 1080 with an expiration date of July 2015 and Batch # 1102 with an expiration date of September 2017. The NDC number for the product is 49807-2304-1.

The products were distributed nationwide in the United States, as well as to Canada, the Philippines, and through internet sales. Consumers should check their supply of Pleo Not Suppositories for the specific batch numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact the distributor or manufacturer for further instructions.

The recalled product

Product
Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — Homeopathic Medicine
Hazard
Affected units
4,860

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 # 1080
  • EXP: July 2015
  • Batch # 1102
  • EXP: Septempber 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 cross contamination

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