Health product recall

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

  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, 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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