Key Takeaway

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. by Natural Essentials Inc was recalled on July 27, 2012. The hazard: Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.

FDA Drug Class III Terminated

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.

Recalled: July 27, 2012 ~11,058 bottles units affected D-1671-2012

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.

Hazard / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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.

Drugs

Company Information

Natural Essentials Inc

Streetsboro, OH, United States

View all 1 recalls by Natural Essentials Inc →

Distribution

Nationwide

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Frequently Asked Questions

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Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.