Esomeprazole, Candesartan and Pravastatin Tablets: OOS result for Finished Product Assay and/or Blend Uniformity
Last updated
Summary
Product
TARO-ESOMEPRAZOLE 20MG, TARO-ESOMEPRAZOLE 40MG, TARO-CANDESARTAN, TARO-PRAVASTATIN
Issue
Health products - Product quality
What to do
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 Delayed release tablets, 20 mg esomeprazole (as esomeprazole magnesium amorphous) | PTB0114A |
| TARO-ESOMEPRAZOLE | TARO-ESOMEPRAZOLE TAB 40MG | DIN 02423987 | Tablet | Esomeprazole Magnesium Delayed Release Tablets Delayed release tablets, 40 mg esomeprazole (as esomeprazole magnesium amorphous) | 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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Recalling Firm:
Sun Pharma Canada Inc. (formerly Ranbaxy Pharmaceuticals Canada Inc.)
126 East Drive, Brampton, ON, L6T 1C1
Published by
Health Canada
Audience
General public
Retail
Recall class
Type II
Identification number
RA-64570
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