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: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Presence of Foreign substance: identified as a dead ant.
Presence of Foreign substance: identified as a dead ant.
Presence of Foreign substance: identified as a dead ant.
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Labeling: Missing label; Product complaints reported missing bottle label.
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol…
Defective Container: Repetitive complaints received indicating pump not working.
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
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.
