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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 62761
Product Type Drugs
Status Ongoing
Recalling Firm Natural Essentials Inc
City Streetsboro
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-27
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2. Lot #: 11741, 11842, 11851, Exp 05/14 Class III Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia. 11,058 bottles D-1671-2012