Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Lupin Pharmaceuticals
Class I - Dangerous
Defective container - seal not adhering to bottles
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Class I - Dangerous
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Failed Content Uniformity Specifications
Defective container: lack of seal integrity.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Subpotent Drug
Labeling: Incorrect or Missing Package Insert
Subpotent Drug and Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Subpotent Drug and Failed Impurities/Degradation Specifications
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Failed Dissolution Specifications
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Subpotent Drug: Low assay result observed during long-term stability testing.
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Class I - Dangerous
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class I - Dangerous
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class I - Dangerous
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Class I - Dangerous
Failed Stability Specification
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Out-of-specification impurity test result observed at 18-month long term stability time point.
Subpotent Drug
Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class I - Dangerous
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Subpotent Drug
Superpotent Drug
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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.
Class I - Dangerous
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.
Class I - Dangerous
Failed Impurities/Degradation Specification; high out of specification results observed
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.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
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 Tablets USP 0.01mg at 12 month long term stability study.
Defective Container: Repetitive complaints received indicating pump not working.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
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 excipient) used in the finished product.
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.
Class I - Dangerous
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.