Reported Jan 20, 2021 · Terminated
Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61,…
Precision Dose Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Precision Dose Inc. · 722 Progressive Ln · South Beloit, IL · 61080-2616
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: a) 502037502040502043Exp 1/31/2021502494502757Exp 8/31/2021502677Exp 9/30/2021502693502728Exp 10/31/2021502771502784Exp 11/30/2021502824Exp 12/31/2021502925Exp 2/28/2022b) 502037502040502043Exp 1/31/2021502494Exp 8/31/2021502759Exp 10/31/2021502771Exp 11/30/2021
- Amount recalled
- 1,107,510 unit dose cups
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
This product could cause temporary or reversible health problems — stop using it.
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