FDA Drug recall D-0613-2018
24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.1…
- FDA Drug
- Class III
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class III recall of 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.1… by Akorn, citing subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0613-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-03-29 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Identifiers
| code_info | Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202522468, 0202522470, Exp 03/1…Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202522468, 0202522470, Exp 03/18; 0202518966, 0202522469, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, 0202548200, Exp 04/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0613-2018%22
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