31 FDA recalls mention Tretinoin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tretinoin.
Reason Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Reason Failed Dissolution Specifications
Reason Superpotent and Subpotent
Reason Superpotent and Subpotent
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Reason Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Reason Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Lack of Processing Control
Reason Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of…
Reason Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Reason Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Reason Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
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