Drug product
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10
D-0696-2018
Product summary
- Event
- Event 79580
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1784 bags
- Official record key
drug-enforcement:D-0696-2018
Official wording
Reason: Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Code information: Lot #: A0A0539, Exp. 05/19
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up