Paroex Oral Rinse Recalled for Potential Bacterial Contamination
Sunstar Americas is recalling Paroex Oral Rinse due to potential Burkholderia cepacia complex contamination and manufacturing facility violations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves potential contamination with Burkholderia cepacia complex, a high-risk pathogen, which aligns with the 'Severe' severity criteria for significant health risks.
Plain-English summary
Sunstar Americas, Inc. is recalling Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, in 1 pint and 4 fl oz bottles. The recall affects all lots with expiration dates from December 31, 2020, through September 30, 2022. The product was distributed nationwide in the United States.
The recall was initiated following an FDA inspection of the manufacturing facility, which identified current Good Manufacturing Practice (cGMP) deviations. The inspection observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions.
Consumers should stop using the recalled product and return it to the pharmacy or point of purchase for a refund. Patients should consult their healthcare provider for alternative treatment options.
The recalled product
- 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
- Manufacturer
- Sunstar Americas, Inc.
- Category
- Drug — Oral Rinse
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 (3)
- ALL LOTS with expiration date from Dec. 31
- 2020 through Sep. 30
- 2022
Distribution
Distributed nationwide across the United States.
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