FDA-Drug2020-12-09Class I

Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15

Lohxa LLC
Hazard

Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.

Sold states
Product was distributed to medical facilities in FL and NY.
Affected count
329 cartons
Manufactured in
600 Main St Ste 110, N/A, Worcester, MA, United States
Products
Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0111-2021

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