Sunstar Americas, Inc.: Drug Recall
Recall #D-0222-2021 · 12/28/2020
Class II: Risk
Recall Details
- Recall Number
- D-0222-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Sunstar Americas, Inc.
- Status
- Ongoing
- Date Initiated
- 12/28/2020
- Location
- Schaumburg, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 1,021,914 bottles; b) 255,552 bottles
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
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
Distribution Pattern
Nationwide USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.