Medications & Supplements/Prescription Drugs

Akorn, Inc.: Chlorhexidine Gluconate Oral Rinse Recalled for Subpotency and Crystallization

Agency Publication Date: March 29, 2018

Summary

Akorn, Inc. is recalling approximately 630,563 unit dose cups of Chlorhexidine Gluconate Oral Rinse (0.12%) and oral care kits containing the rinse because the medication is subpotent. The drug has shown product crystallization and out-of-specification results, meaning it does not contain the correct amount of the active ingredient needed to be effective. These products were distributed nationwide across the United States in various kit formats and individual dose cups.

Risk

The crystallization of the drug leads to a lower-than-intended concentration of chlorhexidine. This subpotency means the oral rinse may not effectively reduce bacteria in the mouth as intended, potentially failing to provide the expected therapeutic benefit to the patient.

What You Should Do

Check your oral rinse packaging for Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups with NDC 50383-720-15 and lot number 350836 with an expiration date of 05/18.
Identify if you have a 24-HOUR Oral Care q2 Kit (Product 97012) or q4 Kit (Product 97014) by Halyard Health, containing the affected 15 mL unit dose cups of oral rinse.
For q2 Kits, check for kit lot numbers 0202511399, 0202511400, 0202543553 (Exp 03/18) and 0202518977, 0202538282, 0202538283, 0202538284, 0202538285, 0202543552, 0202642220, 0202642224, 0202642225 (Exp 04/18).
For q4 Kits, check for kit lot numbers 0202522468, 0202522470 (Exp 03/18) and 0202518966, 0202522469, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, 0202548200 (Exp 04/18).
Contact your healthcare provider or pharmacist for guidance regarding the use of this subpotent medication.
Return any unused product to the pharmacy or place of purchase for a refund and contact Akorn, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

Full Refund

Contact healthcare provider and return 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, 0.12% (15 mL unit dose cups)

Model:

NDC 50383-720-15

NDC 50383-720-18

NDC 50383-720-19

Lot Numbers:

350836 (Exp 05/18)

Date Ranges: May 2018

Product: 24-HOUR Oral Care q2 Kit with Ballard* Technology (Product 97012)

Model:

Product 97012

NDC 50383-720-15

Lot Numbers:

0202511399 (Exp 03/18)

0202511400 (Exp 03/18)

0202543553 (Exp 03/18)

0202518977 (Exp 04/18)

0202538282 (Exp 04/18)

0202538283 (Exp 04/18)

0202538284 (Exp 04/18)

0202538285 (Exp 04/18)

0202543552 (Exp 04/18)

0202642220 (Exp 04/18)

0202642224 (Exp 04/18)

0202642225 (Exp 04/18)

Chlorhexidine Rinse Lot 350836 (Exp 05/18)

Date Ranges: March 2018, April 2018, May 2018

Product: 24-HOUR Oral Care q4 Kit with Ballard* Technology (Product 97014)

Model:

Product 97014

NDC 50383-720-15

Lot Numbers:

0202522468 (Exp 03/18)

0202522470 (Exp 03/18)

0202518966 (Exp 04/18)

0202522469 (Exp 04/18)

0202522471 (Exp 04/18)

0202533449 (Exp 04/18)

0202533456 (Exp 04/18)

0202533463 (Exp 04/18)

0202543351 (Exp 04/18)

0202548200 (Exp 04/18)

Chlorhexidine Rinse Lot 350836 (Exp 05/18)

Date Ranges: March 2018, April 2018, May 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79635

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Halyard Sales, LLC; pharmacies

Manufactured In: United States

Units Affected: 3 products (56,1800 unit dose cups; 48,176 unit dose cups; 20,587 unit dose cups)

Distributed To: Nationwide

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 oral rinse packaging for Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups with NDC 50383-720-15 and lot number 350836 with an expiration date of 05/18.

Identify if you have a 24-HOUR Oral Care q2 Kit (Product 97012) or q4 Kit (Product 97014) by Halyard Health, containing the affected 15 mL unit dose cups of oral rinse.

For q2 Kits, check for kit lot numbers 0202511399, 0202511400, 0202543553 (Exp 03/18) and 0202518977, 0202538282, 0202538283, 0202538284, 0202538285, 0202543552, 0202642220, 0202642224, 0202642225 (Exp 04/18).

For q4 Kits, check for kit lot numbers 0202522468, 0202522470 (Exp 03/18) and 0202518966, 0202522469, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, 0202548200 (Exp 04/18).

Contact your healthcare provider or pharmacist for guidance regarding the use of this subpotent medication.

Return any unused product to the pharmacy or place of purchase for a refund and contact Akorn, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Affected Products

Product: Chlorhexidine Gluconate Oral Rinse, 0.12% (15 mL unit dose cups)

Model:

NDC 50383-720-15

NDC 50383-720-18

NDC 50383-720-19

Lot Numbers:

350836 (Exp 05/18)

Date Ranges: May 2018

Product: 24-HOUR Oral Care q2 Kit with Ballard* Technology (Product 97012)

Model:

Product 97012

NDC 50383-720-15

Lot Numbers:

0202511399 (Exp 03/18)

0202511400 (Exp 03/18)

0202543553 (Exp 03/18)

0202518977 (Exp 04/18)

0202538282 (Exp 04/18)

0202538283 (Exp 04/18)

0202538284 (Exp 04/18)

0202538285 (Exp 04/18)

0202543552 (Exp 04/18)

0202642220 (Exp 04/18)

0202642224 (Exp 04/18)

0202642225 (Exp 04/18)

Chlorhexidine Rinse Lot 350836 (Exp 05/18)

Date Ranges: March 2018, April 2018, May 2018

Product: 24-HOUR Oral Care q4 Kit with Ballard* Technology (Product 97014)

Model:

Product 97014

NDC 50383-720-15

Lot Numbers:

0202522468 (Exp 03/18)

0202522470 (Exp 03/18)

0202518966 (Exp 04/18)

0202522469 (Exp 04/18)

0202522471 (Exp 04/18)

0202533449 (Exp 04/18)

0202533456 (Exp 04/18)

0202533463 (Exp 04/18)

0202543351 (Exp 04/18)

0202548200 (Exp 04/18)

Chlorhexidine Rinse Lot 350836 (Exp 05/18)

Date Ranges: March 2018, April 2018, May 2018