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
Reported: January 20, 2021 Initiated: December 28, 2020 #D-0222-2021
Product Description
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 for Recall
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Details
- Recalling Firm
- Sunstar Americas, Inc.
- Units Affected
- a) 1,021,914 bottles; b) 255,552 bottles
- Distribution
- Nationwide USA
- 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 (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL. Recalled by Sunstar Americas, Inc.. Units affected: a) 1,021,914 bottles; b) 255,552 bottles.
Why was this product recalled? ▼
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 20, 2021. Severity: Moderate. Recall number: D-0222-2021.
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