FDA Drug recall D-1088-2017
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19),…
- FDA Drug
- Class III
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class III recall of Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19),… 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-1088-2017 |
| 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
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.
Reason
Crystallization with subpotent out of specification assay results for chlorhexidine.
Identifiers
| code_info | Lot: 353394, Exp 10-2018 |
|---|
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-1088-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.