Class II
Ongoing
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
This recall is currently active, issued January 20, 2021. It was issued by Sunstar Americas, Inc..
- Company
- Sunstar Americas, Inc.
- Recall Initiated
- December 28, 2020
- Posted
- January 20, 2021
- Recall Number
- D-0222-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 1,021,914 bottles; b) 255,552 bottles
- Firm Location
- Schaumburg, IL, United States
- Official Source
- View on FDA website ↗
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
Nationwide USA
Lot / Code Info
ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022
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