FDA recall D-0103-2019

Product

Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52

Reason for recall

Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Distribution

Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.

Key facts

Status

Terminated

Initiation date

2018-09-12

Report date

2018-10-03

Termination date

2020-03-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0103-2019