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Information Update: Various Lots of Five Prescription Drugs Recalled Due to Product Quality Issues

May 30 2013 12:00AM

Marketwire

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OTTAWA, ONTARIO -- (Marketwired) -- 05/30/13 -- 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.

How to report side effects to health products:

-- Call toll-free at 1-866-234-2345-- Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.



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 Mylan-Lamotrigine 25mg 1055103 --------------1-800-575-1379 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 Lamotrigine 25mg 1055102 --------------1-866-236-4076 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 Riva-Ciprofloxacin 500mg P50281-800-363-7988 P5029--------------------------------------------------------------------------------------------------------------------------------------------------------Cobalt Pharmaceuticals Co Norfloxacin 400mg DN1311-866-254-6111 CS621 CY201 -------------------------------------------------- Co Telmisartan 40mg 135344A 135074A -------------------------------------------------- Co Telmisartan 80mg 135076A 135345A 135075A -------------------------------------------------- Co Telmisartan 80mg/ HCT 135625A 12.5mg -------------------------------------------------- Co Temisartan 80mg / HCT 135627A 25mg----------------------------------------------------------------------------



Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.



Contacts:
Media Inquiries:
Health Canada
613-957-2983

Public Inquiries:
613-957-2991
1-866-225-0709





Source: Marketwire


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