D-0222-2021 Class II Ongoing
FDA drug recall D-0222-2021 was initiated by Sunstar Americas, Inc. on December 28, 2020 and is designated Class II. Reason for recall: cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary c… The recall status is ongoing. Affected quantity: a) 1,021,914 bottles; b) 255,552 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 20, 2021
- Initiation Date
- December 28, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 1,021,914 bottles; b) 255,552 bottles
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
Distribution Pattern
Nationwide USA
Code Information
ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022