Drug recall D-0104-2019

Class III Terminated reported Oct 3, 2018

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.

Lots and codes

Batch Numbers: BS704, EXP 12/018; BS725, EXP 6/2019; BS745, EXP 11/2019.

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
10,530 vials
Distribution
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Type
Voluntary: Firm initiated
Recall initiated
September 12, 2018
Terminated
March 3, 2020

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