# FDA recall D-1001-2019

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2019-03-06.

## Product

Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.

## Reason for recall

Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1001-2019
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-06
- **Report date:** 2019-03-20
- **Termination date:** 2022-05-16

- **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-1001-2019

## Citation

> AI Analytics. FDA recall D-1001-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1001-2019. Source: US FDA. Licensed CC0.

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