FDA recall D-0104-2019

Dr. Reddy's Laboratories, Inc. · Class III · drug

Product

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11

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-0104-2019