FDA Drug recall D-1089-2017
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse
- FDA Drug
- Class III
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class III recall of Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse by Akorn, citing crystallization with subpotent out of specification assay results for chlorhexidine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1089-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-07-12 |
| Published | 2017-08-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Akorn |
| Distribution | US |
Product
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
Reason
Crystallization with subpotent out of specification assay results for chlorhexidine.
Identifiers
| code_info | Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202…Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1089-2017%22
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