# FDA recall D-0784-2016

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2016-03-03.

## Product

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA   NDC 55111-688-52

## Reason for recall

Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0784-2016
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-03
- **Report date:** 2016-04-06
- **Termination date:** 2017-05-03

- **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-0784-2016

## Citation

> AI Analytics. FDA recall D-0784-2016. Retrieved 2026-05-31 from https://api.ai-analytics.org/recall/D-0784-2016. Source: US FDA. Licensed CC0.

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