PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 7, 2016 Initiated: September 9, 2016 #D-0164-2017

Product Description

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

Reason for Recall

Microbial Contamination of Non-Sterile Product

Details

Units Affected
6.0kg
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
Location
Ankleshwar

Frequently Asked Questions

What product was recalled?
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002. Recalled by Cadila Pharmaceuticals Limited. Units affected: 6.0kg.
Why was this product recalled?
Microbial Contamination of Non-Sterile Product
Which agency issued this recall?
This recall was issued by the FDA Drug on December 7, 2016. Severity: Moderate. Recall number: D-0164-2017.