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
D-0104-2019
Product summary
- Event
- Event 81012
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,530 vials
- Official record key
drug-enforcement:D-0104-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Code information: Batch Numbers: BS704, EXP 12/018; BS725, EXP 6/2019; BS745, EXP 11/2019.
Distribution pattern: Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications