Why it was recalled
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Product description
Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541
Lot numbers, UPCs & expiration codes
Lot #: 4052, Exp 01/15; 4063, Exp 02/15; 4150, Exp 03/15.
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-1664-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2012
- FDA report date
- Sep 5, 2012
- Quantity
- 14380 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Capco Custom Packaging Inc
Original FDA data
Every field from FDA enforcement report D-1664-2012, exactly as published.
Show all FDA fields
- City
- Santa Fe Springs
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 62756
- Address
- 10225 Greenleaf Ave
- Code information
- Lot #: 4052, Exp 01/15; 4063, Exp 02/15; 4150, Exp 03/15.
- Postal code
- 90670-3417
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1664-2012
- Classification
- Class II
- Recalling firm
- Capco Custom Packaging Inc
- Product quantity
- 14380 Bottles
- Termination date
- Mar 28, 2013
- Reason for recall
- Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541
- Distribution pattern
- Nationwide and Canada
- Recall initiation date
- Jul 27, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2012