Accuretic (quinapril hydrochloride and hydrochlorothiazide): Nitrosamine Impurity
Summary
Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition may pose a greater health risk. Contact your health care provider to discuss other treatment options
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
Pfizer Accuretic |
Accuretic 20/12.5 mg |
DIN 02237368 |
Tablet |
Hydrochlorothiazide 12.5 mg, Quinapril (Quinapril Hydrochloride) 20 mg |
EF3087, ET9511, EJ5192 |
Pfizer Accuretic |
Accuretic 20/ 25 mg |
DIN 02237369 |
Tablet |
Hydrochlorothiazide 25 mg, Quinapril (Quinapril Hydrochloride) 20 mg |
EA0781, FA3736 |
Pfizer Accuretic |
Accuretic 10/ 12.5 mg |
DIN 02237367 |
Tablet |
Hydrochlorothiazide 12.5 mg, Quinapril (Quinapril Hydrochloride) 10 mg |
FM9526, FA3736, EJ5192 |
Issue
Presence of impurity N-Nitroso-quinapril above the acceptable concentration limit in affected lots.
What you should do
- Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition may pose a greater health risk.
- Contact your health care provider to discuss other treatment options. There is currently a reduced supply of combination quinapril hydrochloride and hydrochlorothiazide nationally; however, other drug products are available for treating high blood pressure.
- If you have questions about the recall, contact Pfizer Canada ULC at 1-800-463-6001 or www.pfizermedinfo.ca for medical inquiries, and at 1-800-387-4974 for general inquiries.
- Report any health product-related side effects or complaints to Health Canada.
Additional information
Previous recalls or alerts
Background
Depth of recall: Wholesalers, Retailers
Details
|
Pfizer Canada ULC H9J 2M5 |
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