Class II · Moderate risk Ongoing
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD…
Reason Failed Dissolution Specifications
3 FDA recalls mention Mycophenolic. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mycophenolic.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications: Low out of specification dissolution results.
Reason Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled as the following drug: METHAZOLAMIDE, Tablet, 50…
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