Drug product
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
D-1334-2022
Product summary
- Event
- Event 90594
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4162 cartons
- Official record key
drug-enforcement:D-1334-2022
Official wording
Reason: Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Code information: Lot: FE22001A, Exp 01/2024
Distribution pattern: Distributed in Ohio
Derived failure modes
-
Potency or specification failure
Subpotent