Drug 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.
D-1671-2012
Product summary
- Event
- Event 62761
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,058 bottles
- Official record key
drug-enforcement:D-1671-2012
Official wording
Reason: Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Code information: Lot #: 11741, 11842, 11851, Exp 05/14
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination