Shilpa Medicare Limited recalls Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, S
Recalled December 16, 2020 · FDA recall D-0121-2021 · Shilpa Medicare
Hazard
CGMP Deviations · FDA Class II
Units
2,064 vials
Sold at
Nationwide in the U.S.
Description
CGMP Deviations
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.
Manufacturer(s)
Shilpa Medicare Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →