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 a) 36000-002-10 and b) 36000-002-06.
D-1033-2018
Product summary
- Event
- Event 80442
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12088 bags
- Official record key
drug-enforcement:D-1033-2018
Official wording
Reason: Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Code information: Lot #: a) A060966, A060967, A060965, A061023, Exp 07/18; b) A060962, Exp 02/19
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent