Drug product
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
D-0164-2017
Product summary
- Event
- Event 75278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6.0kg
- Official record key
drug-enforcement:D-0164-2017
Official wording
Reason: Microbial Contamination of Non-Sterile Product
Code information: Supplied Batch, 150N004; Exp. 08/20 Supplied Batch, 150N006; Exp. 09/20
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
Derived failure modes
-
Microbial contamination
Microbial Contamination