Medicine recalls
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| Canada: Recall: Sensipar (30mg, 60mg, 90mg): Levels of N-nitroso-cinacalcet exceeding the established acceptable intake (AI) limits in affected lots |
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Health Canada announces that Amgen Canada Inc. is recalling the following products from retailers due to levels of N-nitroso-cinacalcet exceeding the established acceptable intake (AI) limits in affected lots:
- Sensipar 30mg Tablet (lot number: 1163742, 1153664, 1140611, 1132162, 1118138, 1122255)
- Sensipar 60mg Tablet (lot number: 1171343, 1162328, 1146254, 1140612, 1133461)
- Sensipar 90mg Tablet (lot number: 1123149, 1118135)
Sensipar (cinacalcet hydrochloride) is indicated for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) receiving dialysis. It controls parathyroid hormone levels, calcium and phosphorous levels, and the serum calcium-phosphorous product, in patients with CKD receiving dialysis. It is also indicated for the reduction of hypercalcemia in patients with parathyroid carcinoma and reduction of clinically significant hypercalcemia, as defined by relevant treatment guidelines, in patients with primary HPT for whom parathyroidectomy is not clinically appropriate or is contraindicated.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/sensipar-30mg-60mg-90mg-levels-n-nitroso-cinacalcet-exceeding-established-acceptable
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Feb 28, 2025
Issued at HKT 15:45
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