In consultation with Health Canada, four companies (Cobalt Pharmaceuticals, Laboratoire Riva, Mylan Pharmaceuticals and Sanis Health) are voluntarily recalling various lots of five prescription drugs (amlodipine, ciprofloxacin, lamotrigine, norfloxacin and telmisartan) from the Canadian market ( see chart below ). The voluntary recall is a precautionary measure due to quality concerns at the manufacturing facility of the active ingredients used in the products. The issues are primarily around processes that affect quality control and oversight. Patients currently using any of these medications who have concerns should contact their healthcare professional to obtain medical advice. However, patients are advised not to discontinue treatment unless directed by their healthcare professional. Healthcare professionals are encouraged to monitor their patients using any of the recalled product lots and report any adverse reaction potentially related to these products to Health Canada. As of May 27, 2013, Health Canada had not received any adverse reactions associated with the affected products. Amlodipine is used in the treatment of hypertension (high blood pressure) and angina (chest pain). Ciprofloxacin and norfloxacin are used in the treatment of various infections (acute bronchitis, urinary tract infections, travellers' diarrhea). Lamotrigine is used in the treatment of epilepsy (seizures). Telmisartan is used in the management of hypertension. Health Canada will monitor the effectiveness of these recalls. This action is not anticipated to disrupt the overall supply for these products, as alternative manufacturers supplying the Canadian market are not affected. The European Directorate for Quality of Medicines & HealthCare made Health Canada aware of its recent inspection of Smruthi Organics Limited, India, where the active pharmaceutical ingredients used in the manufacturing of these products are sourced. This inspection highlighted quality system issues that raised concerns about the quality of the pharmaceutical ingredients manufactured at this facility. Should Health Canada become aware of other affected products or additional lots, the Department will inform Canadians and work with the manufacturers and/or distributors to have the products removed from the marketplace. The following information will help consumers identify the affected products. Consumers wishing more information regarding a company's product are encouraged to contact them directly. Products affected: Company Product Dose Lot Numbers Mylan Pharmaceuticals 1-800-575-1379 Mylan-Lamotrigine 25mg 1055103 1055104 1071320 1071321 1083053 1090443 3003517 Mylan-Lamotrigine 100mg 1055130 1058503 1058504 1064049 1074073 1074074 1074075 1074076 1091053 1091056 1091058 1102541 1102542 1102543 1102545 1102143 1055131 Mylan-Lamotrigine 150mg 1053179 1066559 1066560 1066561 1089653 1089654 Mylan-Amlodipine 5mg 1054209 1055910 1059000 1064414 1070797 1054210 1054210-1 1054211 1055909-1 1055909-2 1058998 1059000-1 1064408 1064409 1064410 1067659 1067660 1067661 1070794 1070795 1070796 1079195 1080906 1080907 1080908 1080909 1082104 1082106 1082107 1082109 1082110 1109035 1109036 1109037 1109038 Mylan-Amlodipine 10mg 1054213 1064419 1067418 1082349 1054214 1054214-1 1054216 1057425 1057426 1060090 1060091 1060092 1060492-1 1064421 1064422 1064423 1067420 1070798 1070799 1070800 1082352 1082353 1082354 1082355 1089757 1089758 1089759 1089760 1089761 1093646-1 1095652 1095654 1097329 1097737 Mylan-Ciprofloxacin 250mg 1105735 1105971 Mylan-Ciprofloxacin 500mg 1097619 1097622 1097625 1097625-1 Mylan-Ciprofloxacin 750mg 1056313 Sanis Health 1-866-236-4076 Lamotrigine 25mg 1055102 1039583 1041529 3003518 1090444 1101442 1071322 Lamotrigine 100mg 1055129 1058502 1039587 1039586 1041900 3001123 1074078 1082097 1082098 1102546 3000279 3001124 1064050 1071323 1071324 1074077 Lamotrigine 150mg 1053182 1053183 3000518 3000519 3000520 1066562 Amlodipine 5mg 1055909 1059001 1064412 1080909 1093431 1054208 1054209 1056778 1058999 1059001 1064412 1064411 1067662 1067661 1079192 1095596 1095598 1095599 3000633 3000567 3000632 3000595 3000583 Amlodipine 10mg 1054218 1070802 1082351 1054216 1054215 1057427 1057428 1060492 1060493 1064424 1067421 1070801 1089753 1089754 1089755 1089756 1097740 1097738 1097739 1097740 3000729 3000675 3000730 3000759 Laboratoire Riva 1-800-363-7988 Riva-Ciprofloxacin 500mg P5028 P5029 Cobalt Pharmaceuticals 1-866-254-6111 Co Norfloxacin 400mg DN131 CS621 CY201 Co Telmisartan 40mg 135344A 135074A Co Telmisartan 80mg 135076A 135345A 135075A Co Telmisartan 80mg/ HCT 12.5mg 135625A Co Temisartan 80mg / HCT 25mg 135627A
RecallTracker