FDA-Drug2016-12-07Class II

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

Cadila Pharmaceuticals Limited
Hazard

Microbial Contamination of Non-Sterile Product

Sold states
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
Affected count
6.0kg
Manufactured in
294, G.I.D.C. Industrial Estate, Ankleshwar, India
Products
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002

Official notice

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

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