FDA-Drug2021-01-20Class II

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.

Precision Dose Inc.
Hazard

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

Sold states
Nationwide USA
Affected count
1,107,510 unit dose cups
Manufactured in
722 Progressive Ln, N/A, South Beloit, IL, United States
Products
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.

Official notice

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

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