FDAClass IIJune 16, 2021

SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse recall: Contamination

SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build…

Why was SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse recalled?

Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build…
Recalling firm
Sunstar Americas, Inc.
Quantity
124064 units
Distribution
Worldwide distribution - US Nationwide distribution and the country of Mexico.
Recall date
June 16, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls