Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 ...
FDA Recall #D-0222-2021 — Class II — December 28, 2020
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
Recalling Firm
Sunstar Americas, Inc. — Schaumburg, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a) 1,021,914 bottles; b) 255,552 bottles
Distribution
Nationwide USA
Code Information
ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated