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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- 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
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