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Sunstar Americas Recalls
6 recalls on record · December 2, 2020 to March 9, 2022 · Drugs, Medical Devices
Recalls by year
20
21
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 9, 2022Medical DevicesFDA
Sunstar Americas, Inc. recalls BUTLER Clear Dip, 12 bottles/case
Hazard: Product lacks premarket clearance.
June 16, 2021Medical DevicesFDA
Sunstar Americas, Inc. recalls SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gin
Hazard: Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
April 21, 2021Medical DevicesFDA
Sunstar Americas, Inc. recalls SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Hazard: Product may be contaminated with Burkholderia contaminans.
March 17, 2021Medical DevicesFDA
Sunstar Americas, Inc. recalls SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is
Hazard: The product may be contaminated with Burkholderia cepacia
January 20, 2021DrugsFDA
Sunstar Americas, Inc. recalls Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-
Hazard: cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
December 2, 2020DrugsFDA
Sunstar Americas, Inc. recalls Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 5237
Hazard: Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.