PlainRecalls
FDA Drug Moderate Class II Terminated

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 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.

Reported: April 16, 2014 Initiated: March 3, 2014 #D-1210-2014

Product Description

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 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.

Reason for Recall

Penicillin Cross Contamination

Details

Recalling Firm
Terra-Medica Inc.
Units Affected
3440 bottles
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Location
Ferndale, WA

Frequently Asked Questions

What product was recalled?
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 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.. Recalled by Terra-Medica Inc.. Units affected: 3440 bottles.
Why was this product recalled?
Penicillin Cross Contamination
Which agency issued this recall?
This recall was issued by the FDA Drug on April 16, 2014. Severity: Moderate. Recall number: D-1210-2014.