Recalls / Class II
Class IID-0228-2021
Product
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.
- Affected lot / code info
- Lot #: a) 502037, 502040, 502043, Exp 1/31/2021; 502494, 502757, Exp 8/31/2021; 502677, Exp 9/30/2021; 502693, 502728, Exp 10/31/2021; 502771, 502784, Exp 11/30/2021; 502824, Exp 12/31/2021; 502925, Exp 2/28/2022; b) 502037, 502040, 502043, Exp 1/31/2021; 502494, Exp 8/31/2021; 502759, Exp 10/31/2021; 502771, Exp 11/30/2021
Why it was recalled
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Recalling firm
- Firm
- Precision Dose Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 722 Progressive Ln, N/A, South Beloit, Illinois 61080-2616
Distribution
- Quantity
- 1,107,510 unit dose cups
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-01-01
- FDA classified
- 2021-01-14
- Posted by FDA
- 2021-01-20
- Terminated
- 2024-07-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0228-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.