Home / Recalls / Sunstar Americas, Inc. / Z-0720-2022

Z-0720-2022 Class II Terminated

Recalled by Sunstar Americas, Inc. — Schaumburg, IL

Recall Details

Product Type
Devices
Report Date
March 9, 2022
Initiation Date
January 14, 2022
Termination Date
August 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22514 ea

Product Description

BUTLER Clear Dip, 12 bottles/case

Reason for Recall

Product lacks premarket clearance.

Distribution Pattern

United States Nationwide distribution.

Code Information

SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD

Other recalls by Sunstar Americas, Inc.

  • Z-1837-2021 Class II — SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - 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 (February 18, 2021)
  • D-0222-2021 Class II — Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, p (December 28, 2020)
  • D-0103-2021 Class I — Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, p (October 27, 2020)