PlainRecalls
FDA Drug Critical Class I Terminated

Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10

Reported: August 14, 2013 Initiated: May 13, 2013 #D-838-2013

Product Description

Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10

Reason for Recall

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

Details

Units Affected
960 Bottles
Distribution
Nationwide
Location
Pennington, NJ

Frequently Asked Questions

What product was recalled?
Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 960 Bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 14, 2013. Severity: Critical. Recall number: D-838-2013.