FDA recall D-0575-2022

Dr. Reddy's Laboratories, Inc. · Class III · drug

Product

Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62

Reason for recall

Failed stability specifications

Distribution

USA Nationwide

Key facts

Status
Terminated
Initiation date
2022-01-19
Report date
2022-03-02
Termination date
2022-12-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0575-2022