FDA recall D-0122-2021

Product

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.

Reason for recall

CGMP Deviations

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2020-12-08

Report date

2020-12-16

Termination date

2022-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Polepally, Jadcherla, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0122-2021