# FDA recall D-1063-2020

> **Breckenridge Pharmaceutical, Inc** · Class III · drug recall initiated 2020-02-24.

## Product

Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.

## Reason for recall

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-1063-2020
- **Recalling firm:** Breckenridge Pharmaceutical, Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-02-24
- **Report date:** 2020-03-04
- **Termination date:** 2020-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berlin, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1063-2020

## Citation

> AI Analytics. FDA recall D-1063-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1063-2020. Source: US FDA. Licensed CC0.

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