14,801 recalls, newest first
Reason Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Reason Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Reason Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Reason Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason CGMP Deviations
Reason Failed dissolution specifications
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.