FDADecember 28, 2020drug
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
What to do
FDA enforcement status: Ongoing
Brands named
sunstar americassunstar
UPCs
05237602104
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCGreenworks Tools Recalls 24V and 48V Kobalt Yard Power Tools with USB-C Batteries Due to Risk of Serious Injury from Fire Hazard2026-07-09
- FDAPhilips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.2026-06-05
- FDAPhilips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A2026-05-26
- FDAPhilips Avalon Fetal Monitor, FM 30 Part numberM2703A2026-05-26
- CPSCPetzl America Recalls SIMBA and SWAN EASYFIT Harnesses Due to Risk of Serious Injury or Death from Fall Hazard2026-05-14
- CPSCPetzl America Recalls ASTRO BOD FAST, ASTRO SIT FAST and CANYON GUIDE Harnesses Due to Risk of Serious Injury or Death from Fall Hazard2026-05-14
- FDADigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.2026-05-01
- CPSCAcer America Corporation Recalls Two-Wheeled Folding Electric Due to Risk of Injury from Fall Hazard2026-04-30
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