Mylan-Cinacalcet: Affected lots exceed the established acceptable intake limit for N-nitroso-cinacalcet.
Last updated
Summary
Product
MYLAN-CINACALCET (30mg, 60mg & 90mg)
Issue
Health products - Product quality
What to do
Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
Distribution
National
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot number |
|---|---|---|---|---|---|
| Mylan | Cinacalcet (30mg) | DIN 02434539 | Tablet | Cinacalcet Hydrochloride 30 mg | 3188963 |
| Mylan | Cinacalcet (60mg) | DIN 02434547 | Tablet | Cinacalcet Hydrochloride 60 mg | 3199204 & 3199206 |
| Mylan | Cinacalcet (90mg) | DIN 02434555 | Tablet | Cinacalcet Hydrochloride 90 mg | 3188964 |
Issue
The affected lots exceed the established acceptable intake limit for N-nitroso-cinacalcet.
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
MYLAN PHARMACEUTICALS ULC
85 Advance Road
Etobicoke ON
M8Z 2S7
Published by
Health Canada
Audience
General public
Healthcare
Industry
Distribution
National
Recall class
Type I
Identification number
RA-77730
Get notified
Receive notifications for new and updated recalls and alerts by category.