D-0612-2018 Class III Terminated
FDA drug recall D-0612-2018 was initiated by Akorn, Inc. on Mar 29, 2018 and is designated Class III. Reason for recall: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. The recall status is terminated (terminated Apr 22, 2020). Affected quantity: 48,176 unit dose cups.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 4, 2018
- Initiation Date
- Mar 29, 2018
- Termination Date
- Apr 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,176 unit dose cups
Product Description
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012.
Reason for Recall
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Distribution Pattern
Nationwide in the USA
Code Information
Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202511399, 0202511400, 0202543553, Exp 03/18; 0202518977, 0202538282, 0202538283, 0202538284, 0202538285, 0202543552, 0202642220, 0202642224, 0202642225, Exp 04/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0612-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026