29 FDA recalls mention Aripiprazole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Aripiprazole.
Reason Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Reason Superpotent drug
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
Reason cGMP Deviations
Reason Out of specification (OOS) for Spectroscopic Identification test by IR.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Reason FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole…
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Reason Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Reason Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions…
Reason Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions…
Reason CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Reason CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Reason Superpotent Drug; out of specification results for assay (manufacturer)
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