Ondansetron HCI API recalled over sterility concerns
- Recall date
- September 9, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Cadila Pharmaceuticals Limited recalls Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
- Recall number
- D-0164-2017
- FDA classification
- Class II
- Brand / firm
- Cadila Pharmaceuticals Limited
- Sold / distributed
- 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
Why it was recalled
Microbial Contamination of Non-Sterile Product
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
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