Sunstar Americas recalls
Sunstar Americas appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2022-03-09.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2020-12-02 to 2022-03-09 |
| By agency | FDA Device (4), FDA Drug (2) |
| By classification | Class II (5), Class I (1) |
| By status | terminated (4), completed (1), ongoing (1) |
| Distribution named in notices | US |
Recalls
- BUTLER Clear Dip, 12 bottles/case
FDA Device · Class II · 2022-03-09 · Sunstar Americas
Reason: Product lacks premarket clearance. - SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by p…
FDA Device · Class II · 2021-06-16 · Sunstar Americas
Reason: Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans. - SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
FDA Device · Class II · 2021-04-21 · Sunstar Americas
Reason: Product may be contaminated with Burkholderia contaminans. - 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 formulated with wat…
FDA Device · Class II · 2021-03-17 · Sunstar Americas
Reason: The product may be contaminated with Burkholderia cepacia - Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02
FDA Drug · Class II · 2021-01-20 · Sunstar Americas
Reason: cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions - Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02
FDA Drug · Class I · 2020-12-02 · Sunstar Americas
Reason: Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.