Drug product
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
D-1032-2018
Product summary
- Event
- Event 80442
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3664 bags
- Official record key
drug-enforcement:D-1032-2018
Official wording
Reason: Failed Stability Specifications: lot out of specification for elevated water vapor.
Code information: Lot #: A0A0156, Exp 02/19
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification