SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
This recall has been terminated (originally issued May 21, 2021).
- Company
- Sunstar Americas, Inc.
- Recall Initiated
- May 21, 2021
- Terminated
- September 4, 2024
- Recall Number
- Z-1837-2021
- Quantity
- 124064 units
- Firm Location
- Schaumburg, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
Distribution
Worldwide distribution - US Nationwide distribution and the country of Mexico.
Lot / Code Info
SKU number 1775P, Lot Numbers: 01U, 02U, 03U, 01Z, 02Z, 03Z, 04Z, 05Z, 01A, 02A, 01B, 02B , 3B SKU number 1775R, Lot Numbers: 01U, 02U, 03U, 01Z, 02Z, 03Z, 04Z, 05Z, 01A, 02A, 01B, 02B , 3B
Root Cause
Under Investigation by firm
Action Taken
The firm initiated the recall by letter on 05/21/2021. The firm is requesting the return of the product and has directed the distributors to notify their customers.
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