Sensipar (30mg, 60mg, 90mg): Levels of N-nitroso-cinacalcet exceeding the established acceptable intake (AI) limits in affected lots.
Brand(s)
Last updated
Summary
Product
Sensipar (30mg, 60mg, 90mg)
Issue
Health products - Product safety
What to do
Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot |
|---|---|---|---|---|---|
| Sensipar | Sensipar 30mg | DIN 02257130 | Tablet | CINACALCET (CINACALCET HYDROCHLORIDE) 30mg | 1163742, 1153664, 1140611, 1132162, 1118138, 1122255 |
| Sensipar | Sensipar 60mg | DIN 02257149 | Tablet | CINACALCET (CINACALCET HYDROCHLORIDE) 60mg | 1171343, 1162328, 1146254, 1140612, 1133461 |
| Sensipar | Sensipar 90mg | DIN 02257157 | Tablet | CINACALCET (CINACALCET HYDROCHLORIDE) 90mg | 1123149, 1118135 |
Issue
Levels of N-nitroso-cinacalcet exceeding the established acceptable intake (AI) limits in affected lots.
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Additional information
Background
Depth of recall: Retailers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Amgen Canada Inc.
6775 Financial Drive, Unit 300,
Mississauga, ON,
L5N 0A4
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-77036
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