D-0104-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 3, 2018
- Initiation Date
- September 12, 2018
- Termination Date
- March 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,530 vials
Product Description
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 Pattern
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Code Information
Batch Numbers: BS704, EXP 12/018; BS725, EXP 6/2019; BS745, EXP 11/2019.