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
Reported: October 3, 2018 Initiated: September 12, 2018 #D-0104-2019
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.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 10,530 vials
- Distribution
- Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 10,530 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 3, 2018. Severity: Low. Recall number: D-0104-2019.
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