Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Impurities/Degradation Specifications
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
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.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Reason Failed Content Uniformity Specifications.
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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