The Recall Desk
SevereFDA (Drugs)·D-1195-2014·Announced 2014-04-16

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

Terra-Medica Inc. is recalling specific batches of Pleo Not DROPS homeopathic medicine 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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a significant allergen contamination (penicillin) which poses a severe risk to sensitive individuals, aligns with the 'Severe' criteria (Score 4).

Plain-English summary

Terra-Medica Inc. is recalling 21,445 bottles of Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine. The recall is due to penicillin cross contamination. The product is an over-the-counter homeopathic medicine made in Germany and distributed by SANUM USA Corp.

The affected batches include Batch # 21049 (EXP: March 2014), Batch # 13059 (EXP: April 2014), Batch # 09080 (EXP: July 2015), Batch #15100 (EXP: September 2015), and Batch # 24092 (EXP: August 2017). The NDC number for the product is 49807-2301-1.

The products were distributed US Nationwide, to Canada, to the Philippines, and through internet sales. Consumers should check their inventory for these specific batch numbers and expiration dates. If the product is found, consumers should stop using it and contact the recalling firm for instructions.

The recalled product

Product
Pleo Not DROPS, 5X, 10 mL Bottles, 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: 49807-2301-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — Homeopathic Medicine
Hazard
Affected units
21,445

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 (10)

  • Batch # 21049
  • EXP: March 2014
  • Batch # 13059
  • EXP: April 2014
  • Batch # 09080
  • EXP: July 2015
  • Batch #15100
  • EXP: September 2015
  • Batch # 24092
  • EXP: August 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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