FDA recall D-0228-2021

Product

Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.

Reason for recall

cGMP deviations: The firm was notified of the manufacturer's expanded recall.

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2021-01-01

Report date

2021-01-20

Termination date

2024-07-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Beloit, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2021