Mycophenolate Mofetil for Injection USP
Reason Presence of precipitate
Class I — High risk. Reasonable probability of serious harm or death.
Microbial contamination
Dr. King's SafeCare Rx Allergies: Fragrances & Phenolics, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955220022, NDC 57955-2205-2
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 Presence of precipitate
Reason Failed Dissolution Specifications
Reason Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP DEVIATIONS
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