Accuretic (quinapril hydrochloride and hydrochlorothiazide): Nitrosamine Impurity
Last updated
Summary
Product
Accuretic (quinapril hydrochloride and hydrochlorothiazide)
Issue
Health products - Contamination
What to 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
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Pfizer Canada ULC H9J 2M5 |
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-63960
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