FDA recall D-0121-2021

Product

Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.

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-0121-2021