Class II · Moderate risk Terminated
Warfarin Sodium Tablets
Reason Failed Impurities/Degradation Specifications
Warfarin Sodium Tablets
Class I — High risk. Reasonable probability of serious harm or death.
Why it was 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.
What 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
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- NDC code
- 68382-053-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-838-2013
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.
Other Warfarin recalls
See all
Class II · Moderate risk Terminated
Warfarin Sodium Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Warfarin Sodium Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Warfarin 2.5 ng Lactose Free Caps
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class III · Low risk Terminated
Warfarin Sodium Tablets
Reason Failed Content Uniformity Specifications.
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