Class II · Moderate risk Terminated
Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC…
Reason Labeling: label error on declared strength.
29 FDA recalls mention Nystatin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nystatin.
Reason Labeling: label error on declared strength.
Reason Labeling: label error on declared strength.
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Reason Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
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