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® | Lead to serious side effects such as cardiovascular disease | |
2 | Reductil® | Lead to serious side effects such as cardiovascular disease | ||
3 | Avandaryl® | Lead to serious side effects such as cardiovascular disease | ||
4 | Avandamet® | Lead to serious side effects such as cardiovascular disease | ||
2 | 5 | Avandia® | Lead to serious side effects such as cardiovascular disease | |
6 | Serevent® | Increased risk of asthma complications requiring hospitalization in children and adults | ||
7 | Sere vent® | Increased risk of asthma complications requiring hospitalization in children and adults | ||
3 | 8 | Oxis® | Increased risk of asthma complications requiring hospitalization in children and adults | |
9 | Foradil® | Increased risk of asthma complications requiring hospitalization in children and adults. | ||
4 | 10 | Augmentin® | 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 |