D-1334-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 17, 2022
- Initiation Date
- July 22, 2022
- Termination Date
- April 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4162 cartons
Product Description
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Reason for Recall
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Distribution Pattern
Distributed in Ohio
Code Information
Lot: FE22001A, Exp 01/2024