Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP violations noted during the firm's most recent inspection.
FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003
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 Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Dissolution Specifications
Reason CGMP Deviations
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