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.

Recall Number: D-0228-2021

Firm: Precision Dose Inc.

Classification: Class II

Status: Terminated

Report Date: 20210120

Initiation Date: 20210101

Termination Date: 20240714

Reason for Recall

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

Product Description

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.