FDA recall D-1334-2022

Teva Pharmaceuticals USA Inc · Class III · 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

Reason for recall

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

Distribution

Distributed in Ohio

Key facts

Status
Terminated
Initiation date
2022-07-22
Report date
2022-08-17
Termination date
2023-04-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1334-2022