7 FDA recalls mention Ciclopirox. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ciclopirox.
Reason Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Reason Defective Container: Firm received complaints of broken tube at the seal.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Reason Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Reason Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Reason Subpotent. drug
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