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.
Reported: December 2, 2020 Initiated: October 27, 2020 #D-0103-2021
Product Description
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.
Reason for Recall
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Details
- Recalling Firm
- Sunstar Americas, Inc.
- Units Affected
- a) 116,662 bottles; b) 13,296 bottles
- Distribution
- USA Nationwide
- Location
- Schaumburg, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sunstar Americas, Inc.. Units affected: a) 116,662 bottles; b) 13,296 bottles.
Why was this product recalled? ▼
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 2, 2020. Severity: Critical. Recall number: D-0103-2021.
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