Esomeprazole, Candesartan and Pravastatin Tablets: OOS result for Finished Product Assay and/or Blend Uniformity

Brand(s)

Last updated

2022-09-21

Summary

Product

TARO-ESOMEPRAZOLE 20MG, TARO-ESOMEPRAZOLE 40MG, TARO-CANDESARTAN, TARO-PRAVASTATIN

Issue

Health products - Product quality

What to do

See instructions below.

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

Out of Specification result for Finished Product Assay and/or Blend Uniformity

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.

Background

Depth of Recall: Retailers

Details

Original published date: 2022-09-21

Alert / recall type

Health product recall