Paroex Oral Rinse recalled over sterility concerns
- Recall date
- October 27, 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 (473 mL) NDC 5237…
- Recall number
- D-0103-2021
- FDA classification
- Class I
- Brand / firm
- Sunstar Americas, Inc.
- Sold / distributed
- USA Nationwide
Why it was recalled
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.
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