Various lots of five prescription drugs recalled due to product quality issues

Starting date:
May 30, 2013
Posting date:
May 30, 2013
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Quality
Audience:
Healthcare Professionals, General Public
Identification number:
RA-33811

Issue

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

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