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Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis ...

FDA Recall #D-1671-2012 — Class III — July 27, 2012

Recall #D-1671-2012 Date: July 27, 2012 Classification: Class III Status: Terminated

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.

Reason for Recall

Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.

Recalling Firm

Natural Essentials Inc — Streetsboro, OH

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

11,058 bottles

Distribution

Nationwide

Code Information

Lot #: 11741, 11842, 11851, Exp 05/14

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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