24-HOUR Oral Care q4 Kit with Ballard* Technology — Class III drug recall D-0613-2018
Terminated recall by Akorn, Inc., reported 2018-04-04, distributed nationwide. Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine a
| Recall number | D-0613-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2018-03-29 |
| Classified | 2018-03-29 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 20,587 units |
| Reason classes | potency, specification failure |
| NDC | 50383-0720-15 |
| Lot numbers | 0202518966, 0202522468, 0202522469, 0202522470, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, 0202548200, 03/18, 04/18, 05/18, 350836 |
Product
24-HOUR Oral Care q4 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 97014.
Reason for recall
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0613-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.