Recall: D-0104-2019

Class III - Minor Violations

Class IIIClassification

2018-09-12Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

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

Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Distribution

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.