Overview of recall records associated with Glenmark Pharmaceuticals Inc., USA, including dates, categories and classifications where available.
Classification mix: Class II: 28, Class III: 3.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Defective Container: Firm received complaints of broken tube at the seal.
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Failed Dissolution Specifications: below specification results
This page summarizes recall records in which the official source identifies Glenmark Pharmaceuticals Inc., USA 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.
