D-1671-2012 Class III Terminated
FDA drug recall D-1671-2012 was initiated by Natural Essentials Inc on July 27, 2012 and is designated Class III. Reason for recall: Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia. The recall status is terminated (terminated January 10, 2014). Affected quantity: 11,058 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 5, 2012
- Initiation Date
- July 27, 2012
- Termination Date
- January 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,058 bottles
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 11741, 11842, 11851, Exp 05/14