Public recall detail

CellCept (mycophenolate mofetil) and MYFORTIC (mycophenolate sodium) - Serious Risk of Teratogenicity in Mycophenolate-Containing Products

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Recall Safety notice
Quick summary

Quick summary: CellCept (mycophenolate mofetil) and MYFORTIC (mycophenolate sodium) - Serious Risk of Teratogenicity in Mycophenolate-Containing Products .

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: CellCept (mycophenolate mofetil) and MYFORTIC (mycophenolate sodium) - Serious Risk of Teratogenicity in Mycophenolate-Containing Products .

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

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Issue

A cumulative review of birth defects has confirmed that mycophenolate is a human teratogen. The evidence showed an increased rate of congenital malformations and spontaneous abortions associated with mycophenolate in comparison with other immunosuppressants.

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