FDA recall D-1671-2012

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-07-27

Report date

2012-09-05

Termination date

2014-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Streetsboro, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1671-2012