Chlorhexidine Gluconate Oral Rinse USP 0 recalled over manufacturing violations

Recall date

January 1, 2021

Source

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

Official notice title

Precision Dose Inc. recalls Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61,…

Recall number

D-0228-2021

FDA classification

Class II

Brand / firm

Precision Dose Inc.

Sold / distributed

Nationwide USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.