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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, 5X, 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: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 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: 49807-2306-2.
Recall Number D-1196-2014
Classification Class II
Code Info (10 x 1mL): Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 06120, EXP: November 2015; Batch #19023; EXP: January 2018. (50 x 1ml) Portable Sips: Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 1110, EXP: October 2015; Batch #6120; EXP: November 2015;Batch # 19023; EXP January 2018.
Product Distributed Qty 730 10 x 1mL Cartons; 367 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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