Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC#…
Reason Failed Impurities/Degradation Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD70636_1, EXP: 5/29/2014.
WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 51672402701
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 Failed Impurities/Degradation Specifications
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.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.