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Table 1 Drug recalls data (January 2010 – January 2019)

From: Medicine recalls in Saudi Arabia: a retrospective review of drug alerts (January 2010–January 2019)

No. of recall letters No. of recall drugs Trade name Reference of recall (web link) Reason of recall
1 1 Sibutral® https://www.sfda.gov.sa/ar/drug/news/pages/699-ar-7-3.aspx Lead to serious side effects such as cardiovascular disease
2 Reductil® https://www.sfda.gov.sa/ar/drug/news/pages/699-ar-7-3.aspx Lead to serious side effects such as cardiovascular disease
3 Avandaryl® https://www.sfda.gov.sa/ar/drug/news/Pages/703-ar-15-3.aspx Lead to serious side effects such as cardiovascular disease
4 Avandamet® https://www.sfda.gov.sa/ar/drug/news/Pages/703-ar-15-3.aspx Lead to serious side effects such as cardiovascular disease
2 5 Avandia® https://www.sfda.gov.sa/ar/drug/news/Pages/703-ar-15-3.aspx Lead to serious side effects such as cardiovascular disease
6 Serevent® https://www.sfda.gov.sa/ar/drug/news/Pages/911-ar-6-11.aspx Increased risk of asthma complications requiring hospitalization in children and adults
7 Sere vent® https://www.sfda.gov.sa/ar/drug/news/Pages/911-ar-6-11.aspx Increased risk of asthma complications requiring hospitalization in children and adults
3 8 Oxis® https://www.sfda.gov.sa/ar/drug/news/Pages/911-ar-6-11.aspx Increased risk of asthma complications requiring hospitalization in children and adults
9 Foradil® https://www.sfda.gov.sa/ar/drug/news/Pages/911-ar-6-11.aspx Increased risk of asthma complications requiring hospitalization in children and adults.
4 10 Augmentin® https://www.sfda.gov.sa/ar/drug/news/Pages/777-31-10.aspx Free from active substances
5 11 Methylprednisolone acetate® https://www.sfda.gov.sa/ar/drug/news/Pages/drugnews1-12-1433-2.aspx contamination with an accidental fungal lead to meningitis
6 12 Yutopar® https://www.sfda.gov.sa/ar/drug/news/Pages/drugnews19-05-13a1.aspx Lead to serious side effects such as cardiovascular disease
7 13 Protelos® https://www.sfda.gov.sa/ar/drug/news/Pages/drognews20-07-2014a1.aspx Lead to serious side effects such as cardiovascular disease
8 14 Omafen® https://www.sfda.gov.sa/ar/drug/news/pages/drug03-03-2016a1.aspx Contamination of small aluminum foil in the strips
9 15 Loric® https://www.sfda.gov.sa/ar/drug/circulations/DocLib2/LORIC-300MG-TABLET.pdf Non-compliance with manufacturer’s specifications-does not pass the solubility test
10 16 Peptac® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/PEPTAC-150MG-TABLET.pdf Non-compliance with manufacturer’s specifications
11 17 Triaxone® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/(sterile_water).pdf Similar trade name of another product
12 18 Enoxirt® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Lidocaine-HCL.pdf An error in packaging stage
13 19 Human albunim ® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Human-Albumin.pdf Contaminated with ethyleneglycol
20 Human albunim® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Human-Albumin.pdf Contaminated with ethyleneglycol
21 Human albunim® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Human-Albumin.pdf Contaminated with ethyleneglycol
22 Human albunim® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Human-Albumin.pdf Contaminated with ethyleneglycol
14 23 Dextrose® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/dextrose.pdf Non-compliance with manufacturer’s specifications—do pass physical test
15 24 Metronidazole® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/METRONIDAZOLE-INJECTION.pdf Non-compliance with manufacturer’s specifications—do pass physical test
16 25 Peptac® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/peptac.pdf Non-compliance with manufacturer’s specifications
17 26 Paracetol® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/paracetol.pdf Non-compliance with manufacturer’s specifications—contaminated with black impurities
18 27 Gentacin ® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/GENTACIN.pdf Non-compliance with manufacturer’s specifications—broken container upon storages
19 28 Olfen® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/olfen1.pdf Non-compliance with manufacturer’s specifications—do not pass solubility test
22 29 Vaxigrip single dose® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/VAXIGRIP.pdf Non-compliance with manufacturer’s specifications
20 30 Omacid® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/OMACID.pdf Non-compliance with manufacturer’s specifications—do not pass assay test
21 31 Jusprin ® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/JUSPRIN-81MG.pdf Non-compliance with manufacturer’s specifications—do pass dissolution test
23 32 Pedovex® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Clopidogrel.pdf Non-compliance with manufacturer’s specifications—do pass bioequivalence test
33 Cardlet® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Clopidogrel.pdf Non-compliance with manufacturer’s specifications—do pass bioequivalence test
34 Vidapart® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Clopidogrel.pdf Non-compliance with manufacturer’s specifications—do pass bioequivalence test
35 Clopex® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Clopidogrel.pdf Non-compliance with manufacturer’s specifications—do pass bioequivalence test
24 36 Clogrel® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/clogrel.pdf Non-compliance with manufacturer’s specifications
25 37 Lynparza® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/LYNPARZA%2050mg.pdf Non-compliance with manufacturer’s specifications—do pass stability test
26 38 Thiamine® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Thiamine100Mg.pdf Do not pass the (friability test) test, which may affect the safety, efficacy of the preparation
27 39 Metaphage® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/MetaphageTablet.PDF Non-compliance with manufacturer’s specifications—do pass bioequivalence test
28 40 Apo-Primidone® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Apo-Primidone250mgTablets.pdf Non-compliance with manufacturer's specifications- higher lead content in the formulation
29 41 Leukeran® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Leukeran2MG.TAB.pdf Non-compliance with manufacturer’s specifications—wrong write for the Arabic name on the container
30 42 Claradone® https://www.sfda.gov.sa/ar/drug/circulations/Documents/CLARADONE-OINTMENT.pdf Non-compliance with manufacturer’s specifications
31 43 Valista® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
44 Valista® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
45 Valista® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
46 Co-valista® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
47 Co-valista® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
48 Co-valista® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
49 Co-valista® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-Nitrosodimethylamine (NDMA), carcinogen
50 Co-valista® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
51 Diostar® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
52 Diostar® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
53 Diostar plus® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
54 Diostar plus® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
55 Diostar plus® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/2948_001.pdf Contamination with N-nitrosodimethylamine (NDMA), carcinogen
32 56 Glymide® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/GlymideDiatab.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay
57 Diatab ® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/GlymideDiatab.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay
33 58 Parazole® https://www.sfda.gov.sa/ar/drug/circulations/Documents/PARAZOLE100.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay
34 59 Taxotere® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Taxotere20mg.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay higher drug concentration than stated
60 Enoxirt® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/3361_001.pdf Change the source of active ingredient without SFDA approval
61 Narapril® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/3361_001.pdf Add different source of the active ingredient without SFDA approval
35 62 Narapril® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/3361_001.pdf Add different source of the active ingredient without SFDA approval
63 Narapril® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/3361_001.pdf Add different source of the active ingredient without SFDA approval
64 Julmentin® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/3361_001.pdf Non-compliance with manufacturer’s specifications—do not change the expiration date from 3 to 2 years
65 Julmentin® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/3361_001.pdf Non-compliance with manufacturer’s specifications—do not change the expiration date from 3 to 2 years
66 Angiotec® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Drug-circ97.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay
67 Angiotec® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Drug-circ97.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay
68 Angiotec® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Drug-circ97.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay
36 69 Lipomax® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Drug-circ97.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay
70 Lipomax® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Drug-circ97.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay
71 Lipomax® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Drug-circ97.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay
72 Dialon® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Drug-circ97.pdf Non-compliance with manufacturer’s specifications—do not pass bioequivalence assay
37 73 Smooderm® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/SmoodermCream.pdf Non-compliance with manufacturer’s specifications—do not write batch number, manufacturing, and expiration date
38 74 Lobet® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/lobet.pdf Non-compliance with manufacturer’s specifications—presence of impurity in the formulation
40 75 Ozurdex® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/OZURDEX.pdf Non-compliance with manufacturer’s specifications—presence of impurity in the formulation
39 76 BCG-medac® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/BCG-medac.pdf Non-compliance with manufacturer’s specifications—errors in quality control of the catheter tubes
41 77 Azimac® https://www.sfda.gov.sa/ar/drug/circulations/Documents/AZIMAC_Film_coated.pdf Non-compliance with manufacturer’s specifications—presence of impurity in the formulation
42 78 Paracetol® https://www.sfda.gov.sa/ar/drug/circulations/Documents/PARACETOL_10_mg.pdf Non-compliance with manufacturer’s specifications—presence of impurity in the formulation
43 79 Cefuzime® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Cefuzime.pdf Non-compliance with manufacturer’s specifications—do not pass dissolution test
44 80 Riazole® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Riazole125mg.pdf Non-compliance with manufacturer’s specifications
45 81 Losanet® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/LOSANET50mg-100mg.pdf Contaminated with toxic carcinogenic material N-nitrosodiethylamine (NDEA)
82 Losanet® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/LOSANET50mg-100mg.pdf Contaminated with toxic carcinogenic material N-nitrosodiethylamine (NDEA)
46 83 Jusprin® https://www.sfda.gov.sa/ar/drug/circulations/DocLib1/Jusprin81mg.pdf Non-compliance with manufacturer’s specifications
47 84 Zordyl® https://www.sfda.gov.sa/ar/drug/news/Pages/d23-1-2019a1.aspx Non-compliance with manufacturer’s specifications—do not pass drug stability test