Drug product
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
D-0605-2018
Product summary
- Event
- Event 79310
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1277 bags
- Official record key
drug-enforcement:D-0605-2018
Official wording
Reason: Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Code information: Lot A060644, May 2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent