D-0164-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 7, 2016
- Initiation Date
- September 9, 2016
- Termination Date
- June 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6.0kg
Product Description
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Reason for Recall
Microbial Contamination of Non-Sterile Product
Distribution Pattern
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
Code Information
Supplied Batch, 150N004; Exp. 08/20 Supplied Batch, 150N006; Exp. 09/20