Class II · Moderate risk Ongoing
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan…
Reason Presence of precipitate
Is Mycophenolate recalled?
10 FDA recalls mention Mycophenolate. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mycophenolate.
Class III · Low risk Terminated
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771…
Reason Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class I · High risk Terminated
Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut…
Reason Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Class III · Low risk Terminated
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing…
Reason cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Class II · Moderate risk Terminated
Mycophenolate Mofetil active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378225001.
Reason Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as the following drug: PRAMIPEXOLE DI-HCL…
Class II · Moderate risk Terminated
MYCOPHENOLATE MOFETIL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00004026001.
Reason Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Tablet, 500 mg may be potentially mis-labeled as the following drug: MYCOPHENOLATE MOFETIL, Capsule…
Class II · Moderate risk Terminated
MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00004025901.
Reason Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as the following drug: CALCIUM ACETATE, Capsule, 667…
Class II · Moderate risk Terminated
MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781206701.
Reason Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN…
Class III · Low risk Terminated
CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b)…
Reason Short Fill: some bottles contained less than 120-count per labeled claim.
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