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 products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Discoloration; Product may not meet specifications for color description once reconstituted.
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.
