Why it was recalled
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0228-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 1, 2021
- FDA report date
- Jan 20, 2021
- Quantity
- 1,107,510 unit dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Precision Dose Inc.
Original FDA data
Every field from FDA enforcement report D-0228-2021, exactly as published.
Show all FDA fields
- City
- South Beloit
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 87081
- Address
- 722 Progressive Ln
- Code information
- 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
- Postal code
- 61080-2616
- Report date
- Jan 20, 2021
- Product type
- Drugs
- Recall number
- D-0228-2021
- Classification
- Class II
- Recalling firm
- Precision Dose Inc.
- Product quantity
- 1,107,510 unit dose cups
- Termination date
- Jul 14, 2024
- Reason for recall
- cGMP deviations: The firm was notified of the manufacturer's expanded recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Jan 1, 2021
- Initial firm notification
- Press Release
- Center classification date
- Jan 14, 2021