Drug recall: Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC…
Class I FDA enforcement event 86656. Recall start date: . Status in the FDA record: Completed.
Reason for recall, in the words of FDA
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Sunstar Americas, Inc. started this drug recall on 27 Oct 2020. The firm address in the FDA record is in Schaumburg, IL. FDA put the recall in Class I. FDA event 86656 has 1 product record. The first FDA enforcement report date is 2 Dec 2020. The record gives the status Completed.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
USA Nationwide
Recalling firm
Sunstar Americas, Inc., Schaumburg, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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) 116,662 bottles; b) 13,296 bottles | Class I | Completed | 2 Dec 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2020
- 342
- Share of these events in Class I
- 15%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Jan 2022 | BUTLER Clear Dip, 12 bottles/case | Device | Class II | 1 |
| 21 May 2021 | SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gin | Device | Class II | 1 |
| 23 Mar 2021 | SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA | Device | Class II | 1 |
| 18 Feb 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 | Device | Class II | 1 |
| 28 Dec 2020 | Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376- | Drug | Class II | 1 |
Official channels
- FDA enforcement report D-0103-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 86656. https://recallregister.com/fda/i/86656/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
USA Nationwide
- What quantity of product is in FDA event 86656?
- The FDA record gives this quantity:
a) 116,662 bottles; b) 13,296 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2020 have the same class?
- 15% of the 342 drug events that started in 2020 are in Class I.