23 FDA recalls mention Dutasteride. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dutasteride.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Reason Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Reason Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: PHENOL, LOZENGE, 29 mg, NDC…
Reason Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule…
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