FDAClass IIApril 16, 2014

Pleo Ex DROPS 5X recall: Contamination

Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248…

Why was Pleo Ex DROPS 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 # 07011; EXP: December 2015; Batch # 09043, EXP: March 2108.

Product
Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248…
Recalling firm
Terra-Medica Inc.
Quantity
3440 bottles
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