TARO-CANDESARTAN: Affected lots were manufactured using an active ingredient that was out of specification for dissolution
Brand(s)
Last updated
Summary
Product
TARO-CANDESARTAN
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 numbers |
|---|---|---|---|---|---|
| TARO | TARO-CANDESARTAN | DIN 02380684 | Tablet | CANDESARTAN CILEXETIL 4 MG | PTG4320A PTG4321A |
| TARO | TARO-CANDESARTAN | DIN 02380692 | Tablet | CANDESARTAN CILEXETIL 8 MG | PTF3333A PTF3338A PTF5487A PTF5488A PTF5489A PTF5490A PTF5491A PTF6159A PTG1103A PTG1083A |
| TARO | TARO- CANDESARTAN | DIN 02380706 | Tablet | CANDESARTAN CILEXETIL 16 MG | PTF3339A PTF5498A PTF5497A PTG1386A PTG1387A PTG1388A |
| RAN | RAN-CANDESARTAN | DIN 02380714 | Tablet | CANDESARTAN CILEXETIL 32 MG | PTF3279A PTF3280A PTF3281A PTF3282A PTF3283A |
Issue
Affected lots were manufactured using an active ingredient that was out of specification for dissolution.
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, Wholesalers, Pharmacies
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
SUN PHARMA CANADA INC
126 East Drive
Brampton, ON
L6T 1C1
Published by
Health Canada
Audience
General public
Healthcare
Industry
Distribution
National
Recall class
Type II
Identification number
RA-81592
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