CanadaTARO‑CANDESARTAN and RAN‑CANDESARTAN candesartan cilexetil tablets (Brand: TARO and RAN; DINs 02380684 [4 mg], 02380692 [8 mg], 02380706 [16 mg], 02380714 [32 mg]) with lot numbers PTG4320A, PTG4321A, PTF3333A, PTF3338A, PTF5487A, PTF5488A, PTF5489A, PTF5490A, PTF5491A, PTF6159A, PTG1103A, PTG1083A, PTF3339A, PTF5498A, PTF5497A, PTG1386A, PTG1387A, PTG1388A, PTF3279A, PTF3280A, PTF3281A, PTF3282A, PTF3283A are affected. They were recalled because the active ingredient was out of specification for dissolution. Verify whether your product is one of the affected lots, consult your healthcare provider before discontinuing use, contact Sun Pharma Canada Inc. with questions, and report any side effects or other safety complaints to Health Canada.
What's being recalled
Depth of recall: Retailers, Wholesalers, Pharmacies
Companies: SUN PHARMA CANADA INC, 126 East Drive, Brampton, ON, L6T 1C1.
How to identify it
Brand: TARO; Product Name: TARO-CANDESARTAN; Market Authorization: DIN 02380684; Dosage Form: Tablet; Strength: CANDESARTAN CILEXETIL 4 MG; Lot numbers: PTG4320A PTG4321A
Brand: TARO; Product Name: TARO-CANDESARTAN; Market Authorization: DIN 02380692; Dosage Form: Tablet; Strength: CANDESARTAN CILEXETIL 8 MG; Lot numbers: PTF3333A PTF3338A PTF5487A PTF5488A PTF5489A PTF5490A PTF5491A PTF6159A PTG1103A PTG1083A
Brand: TARO; Product Name: TARO- CANDESARTAN; Market Authorization: DIN 02380706; Dosage Form: Tablet; Strength: CANDESARTAN CILEXETIL 16 MG; Lot numbers: PTF3339A PTF5498A PTF5497A PTG1386A PTG1387A PTG1388A
Brand: RAN; Product Name: RAN-CANDESARTAN; Market Authorization: DIN 02380714; Dosage Form: Tablet; Strength: CANDESARTAN CILEXETIL 32 MG; Lot numbers: PTF3279A PTF3280A PTF3281A PTF3282A PTF3283A
The hazard
Affected lots were manufactured using an active ingredient that was out of specification for dissolution.
What to 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.
Where it was sold
National
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)