Home / Recalls / Sunstar Americas, Inc. / Z-1382-2021

Z-1382-2021 Class II Terminated

Recalled by Sunstar Americas, Inc. — Schaumburg, IL

Recall Details

Product Type
Devices
Report Date
April 21, 2021
Initiation Date
March 23, 2021
Termination Date
August 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19471 bottles

Product Description

SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

Reason for Recall

Product may be contaminated with Burkholderia contaminans.

Distribution Pattern

US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico

Code Information

Lot Numbers; 532952, 535180, 536513, 536514, 539487, 551038, 551039

Other recalls by Sunstar Americas, Inc.

  • 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 - P (May 21, 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)