Paroex Oral Rinse recalled over manufacturing violations
- Recall date
- December 28, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Sunstar Americas, Inc. recalls Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376…
- Recall number
- D-0222-2021
- FDA classification
- Class II
- Brand / firm
- Sunstar Americas, Inc.
- Sold / distributed
- Nationwide USA
Why it was recalled
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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