Schaumburg, IL, United States
Sunstar Americas, Inc. recalls
6 recalls recorded since 2018, most recently on 14 January 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)1
Terminated or completed5
Class I (FDA)1
Terminated Class II Medical devices
- Recall started
- 14 January 2022
- Terminated
- 28 August 2023
- Reason
- Product lacks premarket clearance.
- Distribution
- United States Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0720-2022
- BUTLER Clear Dip, 12 bottles/case
Terminated Class II Medical devices
- Recall started
- 21 May 2021
- Terminated
- 4 September 2024
- Reason
- Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1837-2021
- SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from pla
Terminated Class II Medical devices
- Recall started
- 23 March 2021
- Terminated
- 28 August 2023
- Reason
- Product may be contaminated with Burkholderia contaminans.
- Distribution
- US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1382-2021
- SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Terminated Class II Medical devices
- Recall started
- 18 February 2021
- Terminated
- 30 September 2024
- Reason
- The product may be contaminated with Burkholderia cepacia
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1182-2021
- 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 water, moisturizers /humectants including one plant-based moisture rich humectant, s
Ongoing Class II Drugs
- Recall started
- 28 December 2020
- Reason
- cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0222-2021
- Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
Completed Class I Drugs
- Recall started
- 27 October 2020
- Reason
- Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0103-2021
- Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.