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Recall Observatory FDA recall evidence

Drug product

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

D-0222-2021

December 28, 2020

Class II

Product summary

Firm
Sunstar Americas, Inc.
Event
Event 87052
Status
Ongoing
Classification
Class II
Quantity
a) 1,021,914 bottles; b) 255,552 bottles
Official record key
drug-enforcement:D-0222-2021

Official wording

Reason: cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions

Code information: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

Distribution pattern: Nationwide USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations
  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Burkholderia cepacia complex (BCC) contamination