Class III
Terminated
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
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- September 12, 2018
- Posted
- October 3, 2018
- Recall Number
- D-0104-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10,530 vials
- Firm Location
- Princeton, NJ, United States
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.
Lot / Code Info
Batch Numbers: BS704, EXP 12/018; BS725, EXP 6/2019; BS745, EXP 11/2019.
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