The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1211-2014·Announced 2014-04-16

Terra-Medica Recalls Pleo Ex Portable Sips Due to Penicillin Contamination

Terra-Medica Inc. is recalling specific batches of Pleo Ex Portable Sips homeopathic medicine due to penicillin cross-contamination.

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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of penicillin allergy.

Plain-English summary

Terra-Medica Inc. is recalling 111 units of Pleo Ex Portable Sips 5X (10 x 1 mL) and 39 units of Pleo Ex Portable Sips 5X (50 x 1 mL) oral homeopathic medicine. The recall is being conducted because the products are contaminated with penicillin.

The affected products are identified by Batch # 09020 with an expiration date of January 2015, and Batch # 03052 with an expiration date of April 2017. These products were distributed nationwide in the United States, as well as to Canada, the Philippines, and through internet sales.

Consumers who have these specific products should stop using them and contact the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral…
Manufacturer
Terra-Medica Inc.
Category
Drug — Homeopathic Medicine
Hazard

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 (5)

  • 10 x 1 mL: Batch # 09020
  • EXP: January 2015
  • Batch # 03052
  • EXP: April 2017. 50 x 1 mL: Batch # 09020
  • EXP: April 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 →

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