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Terminated

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.

FDA Recall Z-1837-2021 · Posted None

Recalling FirmSunstar Americas, Inc.
Recall StatusTerminated
Product CodeNTO
Date Initiated2021-05-21
Date Terminated2024-09-04
Product Quantity124064 units

Reason for Recall

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

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the country of Mexico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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