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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Precision Dose Inc.
- Reason for Recall:
- cGMP deviations: The firm was notified of the manufacturer's expanded recall.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0228-2021
Related Recalls
cGMP Deviations: Product manufactured with contaminated raw ingredient.
cGMP Deviations: Product manufactured with contaminated raw ingredient.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.