Chlorhexidine Gluconate Oral Rinse USP recalled over sterility concerns

Recall date

October 28, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Lohxa LLC recalls Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), pac…

Recall number

D-0111-2021

FDA classification

Class I

Brand / firm

Lohxa LLC

Sold / distributed

Product was distributed to medical facilities in FL and NY.

Why it was recalled

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

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