Reported Dec 7, 2016 · Terminated

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

Cadila Pharmaceuticals Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cadila Pharmaceuticals Limited · 294, G.I.D.C. Industrial Estate · Ankleshwar · N/A

Is this the product you have?

  • Ondansetron HCI API, Bulk
  • ManufacturerCadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Lot codes and dates
    • Supplied Batch
    • 150N004
    • Exp. 08/20 Supplied Batch
    • 150N006
    • Exp. 09/20
Amount recalled
6.0kg

Why it was recalled

Microbial Contamination of Non-Sterile Product

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 29, 2017 · Data as of Sep 19, 7:11 PM UTC

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