Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan…
Reason Presence of precipitate
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Short Fill: some bottles contained less than 120-count per labeled claim.
CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080.
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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