July 2012 FDA Recall Drug by Natural Essentials Inc
D-1671-2012 - Microbial Contamination of a Non-Sterile Products

This Class III drug recall was voluntarily initiated by Natural Essentials Inc on July 27, 2012 for the product Drug. The FDA reported the reason for recall as microbial contamination of a non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1671-2012

Reason for Recall
Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Initiated
07-27-2012
Reported
09-05-2012
Quantity
11,058 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62761
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Natural Essentials Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-10-2014
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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