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

FDA recall notice · announced December 7, 2016 · Cadila Pharmaceuticals Limited

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Microbial Contamination of Non-Sterile Product

Notes

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
Lot/code information: Supplied Batch, 150N004; Exp. 08/20 Supplied Batch, 150N006; Exp. 09/20
Quantity: 6.0kg
Status: Terminated
Products in this recall event:
- Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002 (D-0164-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.