Precision Dose Inc.: Drug Recall
Recall #D-0228-2021 · 01/01/2021
Class II: Risk
Recall Details
- Recall Number
- D-0228-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Precision Dose Inc.
- Status
- Terminated
- Date Initiated
- 01/01/2021
- Location
- South Beloit, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,107,510 unit dose cups
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.
Distribution Pattern
Nationwide USA
Other Recalls by Precision Dose Inc.
- Class II: Risk 11/01/2021
- Class II: Risk 11/01/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.