Drug:
Reaction: PRODUCT DOSE OMISSION ISSUE
20250101 - 20251231
No. 1 - 100
No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
1 | 25491676 |
US |
17 | 1 |
Needle issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
2 | 25491775 |
US |
2 | |
Product dose omission issue, Adverse event, Condition aggravated, |
||||
MACITENTAN, |
||||
3 | 25491838 |
US |
67 | |
Product dose omission issue, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
4 | 25491871 |
US |
85 | 2 |
Wrong technique in device usage process, Product dose omission issue, Accidental exposure to product, |
||||
BELIMUMAB, |
||||
5 | 25491873 |
JP |
2 | |
Pyrexia, Malaise, Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
6 | 25491906 |
US |
49 | 2 |
Rebound atopic dermatitis, Rash, Product dose omission issue, |
||||
DUPILUMAB, |
||||
7 | 25491917 |
US |
1 | |
Dyspnoea, Product dose omission issue, Lacrimation increased, |
||||
DUPILUMAB, FLUTICASONE PROPIONATE AND SALMETEROL, ALBUTEROL SULFATE, MONTELUKAST SODIUM, |
||||
8 | 25491945 |
US |
2 | |
Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
9 | 25491995 |
TR |
||
Device issue, Product dose omission issue, Product administered at inappropriate site, |
||||
GOLIMUMAB, |
||||
10 | 25492078 |
US |
15 | 1 |
Troponin I increased, Product dose omission issue, |
||||
VAMOROLONE, SACUBITRIL AND VALSARTAN, ETEPLIRSEN, LEVOCARNITINE, LEVOCARNITINE ORAL, PREDNISONE, ERGOCALCIFEROL, |
||||
11 | 25492091 |
49 | 2 | |
Product dose omission issue, Fear of injection, |
||||
ADALIMUMAB-RYVK, |
||||
12 | 25492121 |
US |
70 | 2 |
Gastrointestinal disorder, Heart rate decreased, Product dose omission issue, |
||||
LENALIDOMIDE, |
||||
13 | 25492186 |
MX |
45 | 2 |
Needle issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
14 | 25492295 |
US |
71 | 1 |
Product dose omission issue, Incorrect dose administered, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
15 | 25492300 |
US |
1 | |
Product dose omission issue, Intercepted product preparation error, Device malfunction, |
||||
LEUPROLIDE ACETATE, MIRABEGRON, ALLOPURINOL, CARVEDILOL, |
||||
16 | 25492322 |
US |
||
Diarrhoea, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
17 | 25492324 |
US |
2 | |
Product dose omission issue, Product leakage, Device malfunction, |
||||
AZELASTINE HYDROCHLORIDE, AZELASTINE, |
||||
18 | 25492357 |
US |
59 | 2 |
Product dose omission issue, Pain, Rheumatoid arthritis, Product complaint, |
||||
TOCILIZUMAB, |
||||
19 | 25492414 |
CA |
80 | 1 |
Appendicitis, Aortic stenosis, Ascites, Aspiration, Bronchiectasis, Bronchopulmonary aspergillosis allergic, Cardiogenic shock, Congenital hiatus hernia, Diabetes mellitus, End stage renal disease, Hypoxia, Lower respiratory tract infection, Malignant melanoma stage 0, Multiple organ dysfunction syndrome, Myasthenia gravis, Pulmonary embolism, Pulmonary fibrosis, Sepsis, Thrombosis, Ventricular fibrillation, Off label use, Incorrect route of product administration, Intentional product misuse, Product dose omission issue, Product use in unapproved indication, |
||||
INSULIN ASPART, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, ALLOPURINOL, AMIODARONE HYDROCHLORIDE, CEFTRIAXONE, CEFTRIAXONE SODIUM, HYDROCORTISONE ACETATE, LANSOPRAZOLE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE, RAMIPRIL, RAMIPRIL, WARFARIN SODIUM, WARFARIN, BISACODYL, BISACODYL SUPPOSITORIES, BISCODYL, SODIUM FERRIC GLUCONATE COMPLEX, |
||||
20 | 25492471 |
US |
76 | 1 |
Product dose omission issue, |
||||
LENALIDOMIDE, |
||||
21 | 25492484 |
US |
45 | 2 |
Psoriatic arthropathy, Drug ineffective, Product dose omission issue, Device malfunction, |
||||
GUSELKUMAB, |
||||
22 | 25492488 |
GB |
||
Haematemesis, Product use issue, Product dose omission issue, |
||||
ADALIMUMAB-AATY, |
||||
23 | 25492682 |
US |
70 | 1 |
Therapy interrupted, Product dose omission issue, |
||||
LENALIDOMIDE, |
||||
24 | 25492697 |
US |
52 | 1 |
Product dose omission issue, Product dispensing issue, |
||||
LENALIDOMIDE, |
||||
25 | 25492727 |
US |
93 | 2 |
Product dose omission issue, |
||||
LENALIDOMIDE, |
||||
26 | 25492735 |
US |
33 | 1 |
Product dose omission issue, Abdominal discomfort, |
||||
GIVINOSTAT, CARVEDILOL, ERGOCALCIFEROL, NAPROXEN, NAPROXEN SODIUM, LISINOPRIL, EZETIMIBE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, |
||||
27 | 25492746 |
US |
79 | 1 |
Wrong technique in device usage process, Incorrect disposal of product, Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
28 | 25492766 |
US |
||
Product use issue, Product availability issue, Product dose omission issue, No adverse event, |
||||
SUVOREXANT, |
||||
29 | 25492786 |
US |
1 | |
Hallucinations, mixed, Condition aggravated, Product dose omission issue, |
||||
PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE, |
||||
30 | 25492811 |
US |
74 | |
Product dose omission issue, |
||||
LENALIDOMIDE, |
||||
31 | 25492822 |
US |
42 | 1 |
Incorrect dose administered, Product dose omission issue, Increased appetite, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
32 | 25492824 |
US |
65 | 2 |
Product dose omission issue, Incorrect dose administered, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
33 | 25492912 |
US |
2 | |
Product dose omission issue, Product storage error, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
34 | 25492999 |
US |
2 | |
Device defective, Product dose omission issue, Product leakage, |
||||
GUSELKUMAB, |
||||
35 | 25493106 |
US |
||
No adverse event, Product dose omission issue, |
||||
IDURSULFASE, |
||||
36 | 25493120 |
DE |
||
Device issue, Product dose omission issue, Device defective, |
||||
GUSELKUMAB, |
||||
37 | 25493200 |
US |
||
Hot flush, Product dose omission issue, Product use issue, |
||||
RELUGOLIX, RELUGOLIX, ROSUVASTATIN CALCIUM, CLOPIDOGREL, CLOPIDOGREL BISULFATE, FAMOTIDINE, HYDROCHLOROTHIAZIDE, LISINOPRIL, LISINOPRIL, PANTOPRAZOLE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, EZETIMIBE, BUPROPION, FLUTICASONE PROPIONATE AND SALMETEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE, ERGOCALCIFEROL, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, KETOPROFEN, AMITRIPTYLINE HYDROCHLORIDE, BISMUTH SUBSALICYLATE, SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,, CARVEDILOL, AMLODIPINE BESYLATE, |
||||
38 | 25493333 |
US |
88 | 2 |
Accident, Product dose omission issue, |
||||
DULAGLUTIDE, DULAGLUTIDE, |
||||
39 | 25493338 |
US |
2 | |
Product dose omission issue, Product storage error, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
40 | 25493372 |
US |
||
Product dose omission issue, Product commingling, |
||||
OLANZAPINE, FLUOXETINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE, |
||||
41 | 25493491 |
US |
||
Sunburn, Fatigue, Hot flush, Product dose omission issue, |
||||
RELUGOLIX, RELUGOLIX, DOXYCYCLINE, DOXYCYCLINE HYCLATE, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, PREDNISONE, SILDENAFIL CITRATE, SILDENAFIL, |
||||
42 | 25493518 |
US |
2 | |
Oxygen saturation abnormal, Asthma, Respiratory tract infection, Product dose omission issue, Device issue, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
43 | 25493627 |
AT |
66 | 1 |
Product dose omission issue, Product storage error, |
||||
EDOXABAN TOSYLATE, |
||||
44 | 25493793 |
US |
36 | 1 |
Skin lesion, Rash, Product dose omission issue, |
||||
45 | 25493846 |
US |
60 | 2 |
Product dose omission issue, Headache, Decreased appetite, Diarrhoea, Fatigue, |
||||
ABEMACICLIB, |
||||
46 | 25493877 |
US |
||
Product dose omission issue, |
||||
INCOBOTULINUMTOXINA, |
||||
47 | 25493930 |
US |
2 | |
Product dose omission issue, |
||||
PIMAVANSERIN TARTRATE, ALBUTEROL SULFATE, ALBUTEROL, CALCIUM, DIVALPROEX SODIUM, CLONAZEPAM, AMLODIPINE BESYLATE, PREDNISONE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, CARBIDOPA AND LEVODOPA, ERGOCALCIFEROL, SERTRALINE HYDROCHLORIDE, |
||||
48 | 25493975 |
US |
67 | 1 |
Memory impairment, Product dose omission issue, |
||||
PIMAVANSERIN TARTRATE, ALBUTEROL SULFATE, ALBUTEROL, BUPROPION, CHLORTHALIDONE, DONEPEZIL HYDROCHLORIDE, FENOFIBRATE, TAMSULOSIN HYDROCHLORIDE, FLUTICASONE PROPIONATE, TRIPROLIDINE HCL, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, EMPAGLIFLOZIN, LAMOTRIGINE, LISINOPRIL, LORATADINE, LORATADINE ORAL, MELATONIN, MEMANTINE, MEMANTINE HYDROCHLORIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, MONTELUKAST, ROTIGOTINE, SEMAGLUTIDE, ROFLUMILAST, SERTRALINE, ICOSAPENT ETHYL, |
||||
49 | 25493985 |
US |
2 | |
Seizure, Product dose omission issue, |
||||
TROFINETIDE, TROFINETIDE, |
||||
50 | 25494043 |
CH |
||
Device deployment issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
51 | 25494107 |
62 | ||
Product dose omission issue, Respiratory tract congestion, Depressed mood, Total lung capacity abnormal, Arthralgia, Joint swelling, Off label use, |
||||
RUXOLITINIB, BELUMOSUDIL, |
||||
52 | 25494165 |
US |
2 | |
Product communication issue, Product dose omission issue, |
||||
PIMAVANSERIN TARTRATE, LINACLOTIDE, LEVOTHYROXINE, EZETIMIBE, DAPAGLIFLOZIN, FUROSEMIDE, POTASSIUM CHLORIDE, PRAMIPEXOLE, PREDNISONE, LINAGLIPTIN, |
||||
53 | 25494179 |
US |
53 | 2 |
Condition aggravated, Product dose omission issue, |
||||
TOFACITINIB, METHOTREXATE, METHOTREXATE SODIUM, FOLIC ACID, MELOXICAM, |
||||
54 | 25494376 |
US |
70 | 2 |
Blood glucose increased, Product dose omission issue, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, INSULIN ASPART, |
||||
55 | 25494426 |
US |
1 | |
Product dose omission issue, Wrong technique in product usage process, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
56 | 25494464 |
US |
54 | 1 |
Product dose omission issue, Gastrointestinal disorder, Nausea, |
||||
TIRZEPATIDE, |
||||
57 | 25494484 |
US |
55 | 2 |
Product dose omission issue, |
||||
INTERFERON BETA-1B, |
||||
58 | 25494612 |
US |
2 | |
Dementia, Inappropriate schedule of product administration, Product dose omission issue, |
||||
VEDOLIZUMAB, |
||||
59 | 25494671 |
CA |
34 | 2 |
Ludwig angina, Product dose omission issue, Product quality issue, |
||||
CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, TOPIRAMATE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, INDOMETHACIN, MINOCYCLINE, |
||||
60 | 25494709 |
US |
1 | |
Influenza, Malaise, Product dose omission issue, |
||||
MITAPIVAT, |
||||
61 | 25494791 |
US |
60 | 2 |
Accidental exposure to product, Product dose omission issue, Device issue, |
||||
GUSELKUMAB, |
||||
62 | 25494891 |
US |
14 | 2 |
Sleep disorder, Drug ineffective, Product dose omission issue, |
||||
ABROCITINIB, |
||||
63 | 25494933 |
US |
66 | 1 |
Tinnitus, Product dose omission issue, Blood magnesium decreased, |
||||
BUDESONIDE, ALLOPURINOL, ALPRAZOLAM, FENOFIBRATE, LEVOTHYROXINE, LISINOPRIL, MAGNESIUM OXIDE, SERTRALINE, ERGOCALCIFEROL, |
||||
64 | 25495024 |
FR |
64 | 1 |
Device leakage, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
65 | 25495075 |
US |
73 | 2 |
Needle issue, Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
66 | 25495082 |
US |
||
Device leakage, Drug delivery system malfunction, Needle issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
67 | 25495158 |
US |
39 | 1 |
Product dose omission issue, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
68 | 25495234 |
US |
49 | 1 |
Device deployment issue, Product dose omission issue, Injection site pain, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
69 | 25495324 |
US |
58 | 2 |
Product dose omission issue, Glycosylated haemoglobin increased, Incorrect dose administered, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
70 | 25495333 |
US |
78 | |
Off label use, Product storage error, Product dose omission issue, Injection site haemorrhage, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
71 | 25495339 |
US |
64 | 2 |
Product dose omission issue, Extra dose administered, Injection site injury, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
72 | 25495364 |
US |
1 | |
Product dose omission issue, Eating disorder, Glycosylated haemoglobin increased, |
||||
METHYLPHENIDATE HYDROCHLORIDE, |
||||
73 | 25495679 |
US |
23 | 2 |
Dermatitis atopic, Product dose omission issue, Maternal exposure during pregnancy, |
||||
DUPILUMAB, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), CYCLOSPORINE, |
||||
74 | 25495778 |
US |
34 | 2 |
Sleep disorder due to a general medical condition, Rebound atopic dermatitis, Rash, Discomfort, Product dose omission issue, |
||||
DUPILUMAB, |
||||
75 | 25495879 |
US |
23 | 2 |
Rebound eczema, Asthma, Product dose omission issue, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
76 | 25495898 |
US |
32 | 1 |
Pruritus, Product dose omission issue, |
||||
DUPILUMAB, |
||||
77 | 25495936 |
US |
85 | 2 |
Dementia, Product dose omission issue, |
||||
DULAGLUTIDE, |
||||
78 | 25496051 |
US |
48 | 1 |
Back pain, Sleep disorder, Product dose omission issue, |
||||
BUDESONIDE, AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM, ERGOCALCIFEROL, MONTELUKAST SODIUM, PANTOPRAZOLE SODIUM, TELMISARTAN, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, LOSARTAN, ERGOCALCIFEROL, |
||||
79 | 25496082 |
GB |
1 | |
Brain neoplasm, Product dose omission issue, Product prescribing issue, |
||||
SOMATROPIN, |
||||
80 | 25496095 |
US |
25 | 2 |
Acne, Product dose omission issue, |
||||
DEUCRAVACITINIB, |
||||
81 | 25496191 |
US |
53 | 1 |
Condition aggravated, Product dose omission issue, |
||||
TOFACITINIB, |
||||
82 | 25496229 |
US |
2 | |
Device use issue, Product dose omission issue, Device failure, |
||||
ALBUTEROL SULFATE, |
||||
83 | 25496296 |
US |
1 | |
Product dose omission issue, |
||||
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
84 | 25496308 |
US |
1 | |
Product dose omission issue, |
||||
BELIMUMAB, |
||||
85 | 25496359 |
US |
2 | |
White blood cell count decreased, Haemoglobin decreased, Platelet count decreased, Product dose omission issue, |
||||
QUIZARTINIB, |
||||
86 | 25496380 |
US |
9 | 1 |
Rebound atopic dermatitis, Erythema, Product dose omission issue, |
||||
DUPILUMAB, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, ALBUTEROL SULFATE, |
||||
87 | 25496479 |
US |
55 | 2 |
Device malfunction, Drug delivery system malfunction, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, |
||||
88 | 25496500 |
US |
81 | 1 |
Product dose omission issue, |
||||
POMALIDOMIDE, |
||||
89 | 25496502 |
US |
89 | 1 |
Device malfunction, Product delivery mechanism issue, Product dose omission issue, |
||||
ALBUTEROL SULFATE, |
||||
90 | 25496532 |
US |
2 | |
Inappropriate schedule of product administration, Product distribution issue, Product use issue, Insurance issue, Product dose omission issue, |
||||
LANADELUMAB-FLYO, LANADELUMAB-FLYO, LANADELUMAB-FLYO, |
||||
91 | 25496545 |
US |
1 | |
Haemoglobin decreased, Pallor, Underweight, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
92 | 25496633 |
FR |
66 | 1 |
Device occlusion, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
93 | 25496664 |
US |
55 | 2 |
Product dose omission issue, Injection site injury, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
94 | 25490956 |
US |
54 | 1 |
Product dose omission issue, Malaise, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
95 | 25490961 |
US |
12 | 1 |
Rebound atopic dermatitis, Product dose omission issue, Joint swelling, Condition aggravated, Arthralgia, |
||||
DUPILUMAB, |
||||
96 | 25491033 |
US |
80 | 2 |
Pruritus, Product dose omission issue, |
||||
DUPILUMAB, |
||||
97 | 25491042 |
US |
2 | |
Illness, Product dose omission issue, |
||||
DUPILUMAB, THIAMINE HYDROCHLORIDE, ERGOCALCIFEROL, CARIPRAZINE, |
||||
98 | 25491181 |
US |
28 | 2 |
Illness, Product dose omission issue, |
||||
DUPILUMAB, |
||||
99 | 25491214 |
US |
2 | |
Seizure, Product dose omission issue, |
||||
VIGABATRIN, |
||||
100 | 25491237 |
US |
1 | |
Crohn^s disease, Surgery, Product dose omission issue, Needle issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
disclaimer
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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last_updated
2025-07-29