# FDA recall D-0164-2017

> **Cadila Pharmaceuticals Limited** · Class II · drug recall initiated 2016-09-09.

## Product

Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002

## Reason for recall

Microbial Contamination of Non-Sterile Product

## Distribution

According to the firm, the API distributed to two consignees in the US.  See Consignee list below.      Consignee List:    1). LLC LENS Phanna.         Russia    2). Claris  irljectable,        Ahmedabad    3). CPL. Inc, USA

## Key facts

- **Recall number:** D-0164-2017
- **Recalling firm:** Cadila Pharmaceuticals Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-09-09
- **Report date:** 2016-12-07
- **Termination date:** 2017-06-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ankleshwar, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0164-2017

## Citation

> AI Analytics. FDA recall D-0164-2017. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0164-2017. Source: US FDA. Licensed CC0.

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