Health product recall

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: 2022-03-04
Alert / recall type
Health product recall
Category
Health product - Drugs
Companies

Pfizer Canada ULC
17300 Trans-Canada Highway,
Kirkland QC,

H9J 2M5

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-63960