FDA recall D-0111-2021

Product

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

Reason for recall

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

Distribution

Product was distributed to medical facilities in FL and NY.

Key facts

Status

Terminated

Initiation date

2020-10-28

Report date

2020-12-09

Termination date

2022-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Worcester, MA, United States

Primary source

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