Chlorhexidine Gluconate Oral Rinse USP 0.12% recall: CGMP Deviations
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.
Why was Chlorhexidine Gluconate Oral Rinse USP 0.12% recalled?
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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.
- Recalling firm
- Precision Dose Inc.
- Quantity
- 1,107,510 unit dose cups
- Distribution
- Nationwide USA
- Recall date
- January 20, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)