The Recall Desk
SevereFDA (Drugs)·D-1191-2014·Announced 2014-04-16

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

Terra-Medica Inc. is recalling specific batches of Pleo Not Ointment 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 agency classification is FDA Class II, and the hazard involves penicillin cross contamination, which poses a significant risk of allergic reaction or injury, meeting the criteria for a Severe rating.

Plain-English summary

Terra-Medica Inc. is recalling 1,368 tubes of Pleo Not Ointment 3X, 30 g Tube, a topical homeopathic medicine. The recall is being conducted due to penicillin cross contamination. The product is an over-the-counter item manufactured in Germany by SANUM-Kehlbeck GmbH & Co. KG and distributed by SANUM USA Corp.

The affected product includes Batch # 03051 with an expiration date of April 2014, Batch # 13072 with an expiration date of June 2015, and Batch # 21033 with an expiration date of April 2016. The NDC number for the product is 49807-2305-1.

The recalled ointment was distributed nationwide in the United States, as well as to Canada and the Philippines, and was also sold through the internet. Consumers who have this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Pleo Not OINTMENT 3X, 30 g Tube, Topical 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: 49807-2305-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — Topical Homeopathic Medicine
Hazard
Affected units
1,368

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 # 03051
  • EXP: April 2014
  • Batch # 13072
  • EXP: June 2015
  • Batch #21033
  • EXP: April 2016.

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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