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FDAFDA · Food and drugs·Recall number D-0164-2017

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

Published December 7, 2016 · Recall initiated: September 9, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Microbial Contamination of Non-Sterile Product

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Cadila Pharmaceuticals Limited
Distributor
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
Lot
Supplied Batch, 150N004; Exp. 08/20 Supplied Batch, 150N006; Exp. 09/20
Risk classification
Class II
Area (FDA)
drug
Country
India

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