# FDA recall D-0213-2018

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2017-01-09.

## Product

Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11

## Reason for recall

Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.

## Distribution

Distributed nationwide in the USA, Uzbekistan, and Myanmar

## Key facts

- **Recall number:** D-0213-2018
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-01-09
- **Report date:** 2018-01-17
- **Termination date:** 2018-12-04

- **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-0213-2018

## Citation

> AI Analytics. FDA recall D-0213-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0213-2018. Source: US FDA. Licensed CC0.

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