FDA recall D-1349-2022

Amerisource Health Services LLC · Class III · drug

Product

Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56

Reason for recall

Subpotent Drug

Distribution

Nationwide within the USA

Key facts

Status: Terminated
Initiation date: 2022-07-27
Report date: 2022-08-24
Termination date: 2023-09-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1349-2022