The Recall Desk
SevereFDA (Drugs)·D-1194-2014·Announced 2014-04-16

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

Terra-Medica Inc. is recalling Pleo Not Tablets 5X because of 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of penicillin cross-contamination to sensitive individuals.

Plain-English summary

Terra-Medica Inc. is recalling Pleo Not TABLETS 5X, 20 Tablet Cartons, an oral homeopathic medicine. The recall is being conducted due to penicillin cross contamination. The product is an over-the-counter (OTC) medication made in Germany and distributed by SANUM USA Corp. in Fernadale, WA, and manufactured by SANUM-Kehlbeck GmbH & Co. KG.

The recall involves 4,955 cartons of the product. The affected batches are Batch # 15070 with an expiration date of June 2015, and Batch # 24072 with an expiration date of June 2017. The NDC number for the product is 49807-2302-1.

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 their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral 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: 49807-2302-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — Homeopathic Medicine
Hazard
Affected units
4,955

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 # 15070
  • EXP: June 2015
  • Batch # 24072
  • EXP: June 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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