Class II · Moderate risk Terminated
Warfarin Sodium Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Warfarin Sodium Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications
What was recalled
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
- Recalling firm
- Rising Pharmaceuticals
- NDC code
- 57237-119-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0348-2023
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 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.
Class I · High risk Terminated
Coumadin for Injection
Reason Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
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