Drug product
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
D-1031-2018
Product summary
- Event
- Event 80442
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3000 bags
- Official record key
drug-enforcement:D-1031-2018
Official wording
Reason: Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Code information: Lot # A061213, Exp 09/18
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent