FDA recall D-0164-2017

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

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

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