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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 Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2.
Recall Number D-1203-2014
Classification Class II
Code Info 10 x 1 ml: Batch # 13090; EXP: August 2015. 50 x 1 ml: Batch #13090, EXP: August 2015.
Product Distributed Qty 211 10 x 1 ml vials; 152 50 x 1 vials
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.
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