REDDY-SAPROPTERIN: Color change & decrease potency
Brand(s)
Last updated
Summary
Product
REDDY-SAPROPTERIN 100mg powder for solution
Issue
Health products - Product quality
What to do
Consult your health care professional if you have any health concerns.
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
REDDY-SAPROPTERIN |
REDDY-SAPROPTERIN |
DIN 02534533 |
Powder for Solution |
Sapropterin Dihydrochloride for Oral Solution 100mg / sachet |
T2304679 |
Issue
Affected lot recalled due to potential for unexpected colour change leading to potential decreased potency.
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: Wholesalers, retailers and end user
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Dr. Reddy's Laboratories Canada
5580 Explorer Dr, Suite 204,
Mississauga, Ontario, L4W 4Y1
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-75409
History
Change log
2024-05-03: Change in risk type and reason for recall
Get notified
Receive notifications for new and updated recalls and alerts by category.