CanadaAPO‑CANDESARTAN tablets (Apotex Inc.) are affected: candesartan cilexetil 8 mg (DIN 02541297, lot PTG0761A) and 16 mg (DIN 02541300, lots PTF5493B and PTG1028A). They were recalled because the active ingredient in these lots was out of specification for dissolution. Verify whether your product is one of the affected lots, consult your healthcare provider before discontinuing use, contact Apotex 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: APOTEX INC 150 Signet Drive Toronto, ON M9L 1T9.
How to identify it
Brand: APOTEX INC; Product Name: APO-CANDESARTAN TABLETS; Market Authorization: DIN 02541297; Dosage Form: Tablet; Strength: CANDESARTAN CILEXETIL/ 8MG; Lot Number: PTG0761A
Brand: APOTEX INC; Product Name: APO-CANDESARTAN TABLETS; Market Authorization: DIN 02541300; Dosage Form: Tablet; Strength: CANDESARTAN CILEXETIL/16MG; Lot Number: PTF5493B, PTG1028A
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)