Sunstar Americas, Inc.
Sunstar Americas, Inc. appears in FDA public data with 6 recalls — including 1 Class I (most serious) —, 3 510(k) clearances, 9 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0720-2022, Class II) was initiated on January 14, 2022. Its most recent 510(k) clearance was granted on July 13, 2018.
Summary
- Total Recalls
- 6 (1 Class I)
- 510(k) Clearances
- 3
- Inspections
- 9
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0720-2022 | Class II | BUTLER Clear Dip, 12 bottles/case | January 14, 2022 |
| Z-1837-2021 | Class II | SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help p | May 21, 2021 |
| Z-1382-2021 | Class II | SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA | March 23, 2021 |
| Z-1182-2021 | Class II | SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product U | February 18, 2021 |
| D-0222-2021 | Class II | Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pin | December 28, 2020 |
| D-0103-2021 | Class I | Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pin | October 27, 2020 |