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.
Reported: January 20, 2021 Initiated: January 1, 2021 #D-0228-2021
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.
Reason for Recall
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Details
- Recalling Firm
- Precision Dose Inc.
- Units Affected
- 1,107,510 unit dose cups
- Distribution
- Nationwide USA
- Location
- South Beloit, IL
Frequently Asked Questions
What product 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.. Recalled by Precision Dose Inc.. Units affected: 1,107,510 unit dose cups.
Why was this product recalled? ▼
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 20, 2021. Severity: Moderate. Recall number: D-0228-2021.
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