# FDA recall D-0104-2019

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2018-09-12.

## 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

## 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.

## Key facts

- **Recall number:** D-0104-2019
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-12
- **Report date:** 2018-10-03
- **Termination date:** 2020-03-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0104-2019

## Citation

> AI Analytics. FDA recall D-0104-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0104-2019. Source: US FDA. Licensed CC0.

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