The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1208-2014·Announced 2014-04-16

Terra-Medica Recalls Pleo Fort Tablets Due to Penicillin Cross Contamination

Terra-Medica Inc. is recalling Pleo Fort Tablets 5X due to penicillin cross-contamination. The product was distributed nationwide and internationally.

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 4,770 cartons of Pleo Fort Tablets 5X, a homeopathic digestive aid medicine. The recall is being conducted because the product is subject to penicillin cross-contamination. The affected product is an over-the-counter medicine made in Germany and distributed by SANUM USA Corp.

The recalled product includes specific batches with expiration dates of September 2015, October 2015, and January 2018. The NDC for the product is 49807-1102-1. Distribution occurred across the United States, Canada, the Philippines, and through internet sales.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. The source text does not specify the number of units sold or any reported illnesses.

The recalled product

Product
Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1.
Manufacturer
Terra-Medica Inc.
Category
Drug — Over-the-Counter Medicine
Hazard
Affected units
4,770

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 # 27100
  • EXP: September 2015
  • Batch # 29100
  • EXP: October 2015
  • Batch # 25013
  • EXP: January 2018.

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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