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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

Product Description Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal 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: 49807-1001-1.
Recall Number D-1209-2014
Classification Class II
Code Info Batch # 2011; EXP: December 2015; Batch # 2081, EXP: July 2016; Batch # 3063, EXP: May 2018; Batch # 1013, EXP: February 2018.
Product Distributed Qty 5940 Packages
Reason For Recall Penicillin Cross Contamination

Event Detail

Event Id 67723
Product Type Drugs
Status Ongoing
Recalling Firm Terra-Medica Inc.
City Ferndale
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-03
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.