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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description 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.
Recall Number D-1671-2012
Classification Class III
Code Info Lot #: 11741, 11842, 11851, Exp 05/14
Product Distributed Qty 11,058 bottles
Reason For Recall Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.

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