Status
Terminated
Drug Enforcement D-1671-2012
Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Classification
Class III
Report Date
September 5, 2012
Termination Date
January 10, 2014
Product Information
- 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.
- Product quantity
- 11,058 bottles
- Reason for recall
- Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Natural Essentials Inc
- Address
-
1800 Miller Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1671-2012
- Event ID
- 62761
- Recall initiation date
- July 27, 2012
- Center classification date
- August 30, 2012
- Code info
- Lot #: 11741, 11842, 11851, Exp 05/14
- More code info
- —