Drug product
Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India
D-0124-2018
Product summary
- Event
- Event 78504
- Status
- Terminated
- Classification
- Class III
- Quantity
- 24,569 bags
- Official record key
drug-enforcement:D-0124-2018
Official wording
Reason: Superpotent
Code information: a) A060174 01/13/2018, A060257 02/28/2018, A060692 05/31/2018, A061165 09/30/2018, A0A0143 01/31/2019, A0A0347 03/31/2019, and A0A0424 04/30/2019 ; b) A060027 12/31/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent