Esomeprazole, Candesartan and Pravastatin Tablets: OOS result for Finished Product Assay and/or Blend Uniformity
Summary
See instructions below.
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
TARO-ESOMEPRAZOLE |
TARO-ESOMEPRAZOLE TAB 20MG |
DIN 02423979 |
Tablet |
Esomeprazole Magnesium Delayed Release Tablets |
PTB0114A |
TARO-ESOMEPRAZOLE |
TARO-ESOMEPRAZOLE TAB 40MG |
DIN 02423987 |
Tablet |
Esomeprazole Magnesium Delayed Release Tablets |
AB92948, AB94331A, PTC0254A, PTC0695A |
TARO-CANDESARTAN |
TARO-CANDESARTAN TABS 16MG |
DIN 02380706 |
Tablet |
Candesartan cilexetil tablets 16 mg |
PTB0041A |
TARO-PRAVASTATIN |
TARO-PRAVASTATIN 10MG |
DIN 02284421 |
Tablet |
Pravastatin Sodium Tablets 10 mg |
AB76493 |
Issue
Out of Specification result for Finished Product Assay and/or Blend Uniformity
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
Recalling Firm:
Sun Pharma Canada Inc. (formerly Ranbaxy Pharmaceuticals Canada Inc.)
126 East Drive, Brampton, ON, L6T 1C1