Drug 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.
D-1088-2017
Product summary
- Firm
- Akorn Inc
- Event
- Event 77822
- Status
- Terminated
- Classification
- Class III
- Quantity
- 541,900 unit dose cups (5,419 trays)
- Official record key
drug-enforcement:D-1088-2017
Official wording
Reason: Crystallization with subpotent out of specification assay results for chlorhexidine.
Code information: Lot: 353394, Exp 10-2018
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
subpotent