Agency classClass IOur severity:Severe FDA (Drugs)·D-0103-2021·Announced 2020-12-02

Paroex Oral Rinse Recalled for Burkholderia lata Contamination

Sunstar Americas is recalling Paroex Oral Rinse due to microbial contamination with Burkholderia lata. The recall covers specific lots distributed nationwide.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric. The hazard involves microbial contamination with Burkholderia lata, a pathogen associated with serious infections.

Plain-English summary

Sunstar Americas, Inc. is recalling Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, which is a prescription-only product. The recall is being conducted because the non-sterile product was found to be contaminated with the microorganism Burkholderia lata.

The affected products are packaged in 1 pint (473 mL) bottles (NDC 52376-021-02) and 4 fl oz (118 mL) bottles (NDC 52376-021-04). The recall includes specific lot numbers with expiration dates ranging from July 31, 2020, to September 30, 2022. The total quantity involved is 116,662 bottles of the 1 pint size and 13,296 bottles of the 4 fl oz size.

These products were distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be discontinued and returned to the supplier or disposed of according to local regulations.

The recalled product

Product: 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.
Manufacturer: Sunstar Americas, Inc.
Category: Drug — Oral Rinse
Hazard: microbial-contamination
infection

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot #: a) C170FY
C170FZ
C170GA
C170GB
C170GC
C177GP
C177GQ
C177GR
Exp 6/30/2022
C191KS
C191KT
C191KU
C191KW
C191KX
C191KY
C198LJ
C198LK
C198LL
C198LM
C205BH

Distribution

Distributed nationwide across the United States.

Same manufacturer · Sunstar Americas, Inc.

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