9 FDA recalls mention Irinotecan. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Irinotecan.
Reason CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations…
Reason Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Reason Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Reason Lack of Assurance of Sterility
Reason Superpotent Drug: High out of specification assay value results for potency.
Reason Superpotent Drug: High out of specification assay value results for potency.
Reason Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in…
Reason Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in…
Reason Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
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