The Recall Desk
HighFDA (Drugs)·D-1193-2014·Announced 2014-04-16

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

Terra-Medica Inc. is recalling Pleo Not Capsules 4X because of penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk allergen (penicillin) cross-contamination in a drug product. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

Terra-Medica Inc. is recalling Pleo Not CAPSULES 4X, an oral homeopathic medicine used as a fever reducer, cough suppressant, and decongestant. The recall is due to penicillin cross contamination. The affected product is sold in 20-tablet cartons and is labeled as OTC only.

The recalled product was distributed nationwide in the United States, as well as to Canada and the Philippines, and through internet sales. The specific batches involved are Batch # 14010 (expiration December 2014), Batch # 11080 (expiration August 2015), and Batch # 12092 (expiration July 2017). The total quantity recalled is 7,408 cartons.

Consumers who have purchased this product should stop using it and contact the recalling firm or their healthcare provider for further instructions, particularly if they have a known penicillin allergy.

The recalled product

Product
Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant 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: 49807-2303-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — OTC Homeopathic
Hazard
Affected units
7,408

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 (6)

  • Batch # 14010
  • EXP: December 2014
  • Batch # 11080
  • EXP: August 2015
  • Batch # 12092
  • EXP: July 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 · allergen penicillin

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