SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product recall — FDA Z-1837-2021
Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
Overview of recall records associated with Sunstar Americas, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 3, Class I: 1.
Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
The product may be contaminated with Burkholderia cepacia
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and…
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
This page summarizes recall records in which the official source identifies Sunstar Americas, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.