FDAFDA · Food and drugs·Recall number D-0104-2019
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
Published October 3, 2018 · Recall initiated: September 12, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ZOLEDRONIC ACID
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
- Lot
- Batch Numbers: BS704, EXP 12/018; BS725, EXP 6/2019; BS745, EXP 11/2019.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.