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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 Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-2 .
Recall Number D-1197-2014
Classification Class II
Code Info (10 x 1mL) Batch # 25050, EXP: April 2015. (50 x 1mL): Batch # 25050, EXP: April 2015.
Product Distributed Qty 55 10 x 1 mL Cartons; 51 50 x 1 mL Cartons
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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