FDAFDA · Food and drugs·Recall number 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; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
Published January 20, 2021 · Recall initiated: December 28, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Sunstar Americas, Inc.
- Distributor
- Nationwide USA
- Lot
- ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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