Why it was recalled
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Product description
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
Lot numbers, UPCs & expiration codes
SKU #12977-00 (Cassette - 1 Liter), Lot #: SA1229ANB; b) SKU #12979-00 (E-Cassette - 1.2 Liters), Lot #: SA1229ANA, Exp 08/13
Where it was sold
Nationwide and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1414-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 14, 2012
- FDA report date
- Jul 18, 2012
- Quantity
- 5268 Cassettes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kimberly-Clark Corporation
Original FDA data
Every field from FDA enforcement report D-1414-2012, exactly as published.
Show all FDA fields
- City
- Roswell
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 62418
- Address
- 1400 Holcomb Bridge Rd
- Code information
- SKU #12977-00 (Cassette - 1 Liter), Lot #: SA1229ANB; b) SKU #12979-00 (E-Cassette - 1.2 Liters), Lot #: SA1229ANA, Exp 08/13
- Postal code
- 30076
- Report date
- Jul 18, 2012
- Product type
- Drugs
- Recall number
- D-1414-2012
- Classification
- Class II
- Recalling firm
- Kimberly-Clark Corporation
- Product quantity
- 5268 Cassettes
- Termination date
- Apr 9, 2013
- Reason for recall
- Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Canada
- Recall initiation date
- Jun 14, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 12, 2012