Drug product
Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
D-1414-2012
Product summary
- Event
- Event 62418
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5268 Cassettes
- Official record key
drug-enforcement:D-1414-2012
Official wording
Reason: Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Code information: SKU #12977-00 (Cassette - 1 Liter), Lot #: SA1229ANB; b) SKU #12979-00 (E-Cassette - 1.2 Liters), Lot #: SA1229ANA, Exp 08/13
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Microbial contamination
Microbial Contamination