Why it was recalled
Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
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.
Lot numbers, UPCs & expiration codes
Lot #: 11741, 11842, 11851, Exp 05/14
Where it was sold
Nationwide
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-1671-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 27, 2012
- FDA report date
- Sep 5, 2012
- Quantity
- 11,058 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Natural Essentials Inc
Original FDA data
Every field from FDA enforcement report D-1671-2012, exactly as published.
Show all FDA fields
- City
- Streetsboro
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 62761
- Address
- 1800 Miller Pkwy
- Code information
- Lot #: 11741, 11842, 11851, Exp 05/14
- Postal code
- 44241-5067
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1671-2012
- Classification
- Class III
- Recalling firm
- Natural Essentials Inc
- Product quantity
- 11,058 bottles
- Termination date
- Jan 10, 2014
- Reason for recall
- Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 27, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 30, 2012