Reported Aug 14, 2013 · Terminated

Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad,…

Zydus Pharmaceuticals USA Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle
  • Manufactured byCadila Healthcare Ltd Ahmedabad, India
  • Distributed byZydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10
Lot codes and dates
  • Lot MM5767
Amount recalled
960 Bottles

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated May 5, 2015 · Data as of Sep 19, 5:54 PM UTC

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