Medications & Supplements/Prescription Drugs

Precision Dose Inc.: Chlorhexidine Gluconate Oral Rinse Recalled for Manufacturing Deviations

Agency Publication Date: January 14, 2021

Summary

Precision Dose Inc. is recalling approximately 1,107,510 unit dose cups of Chlorhexidine Gluconate Oral Rinse USP 0.12% (an antiseptic mouthwash). The recall was initiated because the manufacturer reported deviations from Current Good Manufacturing Practice (cGMP) requirements. These 15 mL unit dose cups were distributed nationwide in cases of 30 or 100 packs to healthcare facilities and pharmacies between 2021 and 2022. Consumers and healthcare providers should check their supplies for the specific lot numbers and expiration dates listed below.

Risk

Manufacturing deviations can lead to products that do not meet quality standards or safety specifications, potentially resulting in ineffective treatment or unintended side effects for patients using the oral rinse.

What You Should Do

Check your medication supply for Chlorhexidine Gluconate Oral Rinse USP 0.12% packaged in 15 mL unit dose cups labeled as Precision Dose, Inc.
Identify if your product is affected by matching the Lot Number and Expiration Date. For 30-pack cases (NDC 68094-028-61), look for lots: 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); or 502925 (Exp 2/28/2022).
For 100-pack cases (NDC 68094-028-62), look for lots: 502037, 502040, 502043 (Exp 1/31/2021); 502494 (Exp 8/31/2021); 502759 (Exp 10/31/2021); or 502771 (Exp 11/30/2021).
Contact your healthcare provider or pharmacist immediately for guidance if you are using an affected lot and to obtain a replacement prescription.
Return any unused unit dose cups to the pharmacy or place of purchase for a refund and contact Precision Dose Inc. for further instructions.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

Full Refund

Refund for unused product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Chlorhexidine Gluconate Oral Rinse USP 0.12% (15 mL x 30 Unit Dose Cups)

Model:

NDC 68094-028-61

Recall #: D-0228-2021

Lot Numbers:

502037 (Exp 1/31/2021)

502040 (Exp 1/31/2021)

502043 (Exp 1/31/2021)

502494 (Exp 8/31/2021)

502757 (Exp 8/31/2021)

502677 (Exp 9/30/2021)

502693 (Exp 10/31/2021)

502728 (Exp 10/31/2021)

502771 (Exp 11/30/2021)

502784 (Exp 11/30/2021)

502824 (Exp 12/31/2021)

502925 (Exp 2/28/2022)

Date Ranges: Expiration dates through 2/28/2022

Product: Chlorhexidine Gluconate Oral Rinse USP 0.12% (15 mL x 100 Unit Dose Cups)

Model:

NDC 68094-028-62

Recall #: D-0228-2021

Lot Numbers:

502037 (Exp 1/31/2021)

502040 (Exp 1/31/2021)

502043 (Exp 1/31/2021)

502494 (Exp 8/31/2021)

502759 (Exp 10/31/2021)

502771 (Exp 11/30/2021)

Date Ranges: Expiration dates through 11/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87081

Status: Resolved

Manufacturer: Precision Dose Inc.

Sold By: Pharmacies; Healthcare facilities

Manufactured In: United States

Units Affected: 1,107,510 unit dose cups

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication supply for Chlorhexidine Gluconate Oral Rinse USP 0.12% packaged in 15 mL unit dose cups labeled as Precision Dose, Inc.

Identify if your product is affected by matching the Lot Number and Expiration Date. For 30-pack cases (NDC 68094-028-61), look for lots: 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); or 502925 (Exp 2/28/2022).

For 100-pack cases (NDC 68094-028-62), look for lots: 502037, 502040, 502043 (Exp 1/31/2021); 502494 (Exp 8/31/2021); 502759 (Exp 10/31/2021); or 502771 (Exp 11/30/2021).

Contact your healthcare provider or pharmacist immediately for guidance if you are using an affected lot and to obtain a replacement prescription.

Return any unused unit dose cups to the pharmacy or place of purchase for a refund and contact Precision Dose Inc. for further instructions.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Affected Products

Product: Chlorhexidine Gluconate Oral Rinse USP 0.12% (15 mL x 30 Unit Dose Cups)

Model:

NDC 68094-028-61

Recall #: D-0228-2021

Lot Numbers:

502037 (Exp 1/31/2021)

502040 (Exp 1/31/2021)

502043 (Exp 1/31/2021)

502494 (Exp 8/31/2021)

502757 (Exp 8/31/2021)

502677 (Exp 9/30/2021)

502693 (Exp 10/31/2021)

502728 (Exp 10/31/2021)

502771 (Exp 11/30/2021)

502784 (Exp 11/30/2021)

502824 (Exp 12/31/2021)

502925 (Exp 2/28/2022)

Date Ranges: Expiration dates through 2/28/2022

Product: Chlorhexidine Gluconate Oral Rinse USP 0.12% (15 mL x 100 Unit Dose Cups)

Model:

NDC 68094-028-62

Recall #: D-0228-2021

Lot Numbers:

502037 (Exp 1/31/2021)

502040 (Exp 1/31/2021)

502043 (Exp 1/31/2021)

502494 (Exp 8/31/2021)

502759 (Exp 10/31/2021)

502771 (Exp 11/30/2021)

Date Ranges: Expiration dates through 11/30/2021