FDAClass IIApril 16, 2014

Pleo Fort TABLETS 5X recall: Contamination

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.

Why was Pleo Fort TABLETS 5X recalled?

Penicillin Cross Contamination

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
Terra-Medica Inc.
Quantity
4770 Cartons
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Recall date
April 16, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls