Health product recall

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

  1. Verify if your product is affected.
  2. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
  3. Contact the recalling firm if you have any questions about the recall.
  4. Report any health product related side effects to Health Canada.
  5. 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