Overview of recall records associated with Glenmark Pharmaceuticals Inc., USA, including dates, categories and classifications where available.
Classification mix: Class II: 47, Class III: 12, Class I: 2.
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
CGMP Deviations
Failed Dissolution Specifications
Failed Dissolution Specifications
CGMP Deviations
Failed Dissolution Specifications: results below specifications
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability…
Failed Dissolution Specifications: Out of specification for dissolution.
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Defective Container: Tube split from side seam
Defective Container
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.
