FDA Drug recall 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
- FDA Drug
- Class II
- ongoing
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02 by Sunstar Americas, citing cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological test….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0222-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-28 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sunstar Americas |
| Distribution | US |
Product
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
Reason
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Identifiers
| code_info | ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Sunstar Americas
- BUTLER Clear Dip, 12 bottles/case
FDA Device · Class II · 2022-03-09 · Sunstar Americas - SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by p…
FDA Device · Class II · 2021-06-16 · Sunstar Americas - SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
FDA Device · Class II · 2021-04-21 · Sunstar Americas - 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 wat…
FDA Device · Class II · 2021-03-17 · Sunstar Americas - Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02
FDA Drug · Class I · 2020-12-02 · Sunstar Americas
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0222-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.