Recalls / Class III
Class IIID-0104-2019
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
- Brand name
- Zoledronic Acid
- Generic name
- Zoledronic Acid
- Active ingredient
- Zoledronic Acid
- Route
- Intravenous
- NDC
- 43598-331
- FDA application
- ANDA091363
- Affected lot / code info
- Batch Numbers: BS704, EXP 12/018; BS725, EXP 6/2019; BS745, EXP 11/2019.
Why it was recalled
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 10,530 vials
- Distribution pattern
- Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Timeline
- Recall initiated
- 2018-09-12
- FDA classified
- 2018-10-26
- Posted by FDA
- 2018-10-03
- Terminated
- 2020-03-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0104-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.