US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 9, 2016 (10 years ago)

Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Microbial Contamination of Non-Sterile Product

What was recalled

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

Recalling firm
Cadila Pharmaceuticals Limited
Origin
India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0164-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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