Overview of recall records associated with Lupin Pharmaceuticals Inc., including dates, categories and classifications where available.
Classification mix: Class II: 63, Class III: 35, Class I: 5.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an…
CGMP Deviation; manufacturing batch record could not be located
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Defective Container: Repetitive complaints received indicating pump not working.
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
This page summarizes recall records in which the official source identifies Lupin Pharmaceuticals Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
