Health product recall

Inderal-LA: Nitrosamine Impurity

Last updated

Summary

Product
Inderal-LA (propranolol hydrochloride) extended release capsules, in 60 mg, 80 mg, 120 mg and 160 mg strengths
Issue
Health products - Contamination
What to do

Contact your health care provider to discuss other treatment options. While there are no other companies marketing extended release propranolol in Canada, immediate release propranolol products continue to be available, along with other treatment options. Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition poses a greater health risk. 

Affected products

Brand

Product Name

Market Authorization

Dosage Form

Strength

Lot

Pfizer Inderal-LA

Inderal-LA 60mg

DIN 02042231

Capsule (Extended Release)

Propanolol Hydrochloride 60mg

EX7461, EH5907, DX6150

Pfizer Inderal-LA

Inderal-LA 80mg

DIN 02042258

Capsule (Extended Release)

Propanolol Hydrochloride 80mg

EX7462, EL1695, EE7221, DW8242

Pfizer Inderal-LA

Inderal-LA 120mg

DIN 02042266

Capsule (Extended Release)

Propanolol Hydrochloride 120mg

FE0541, EH5908, DX6159, DJ6820

Pfizer Inderal-LA

Inderal-LA 160mg

DIN 02042274

Capsule (Extended Release)

Propanolol Hydrochloride 160mg

FE6304, EH5906, DW8241

Issue

 Presence of impurity N-Nitroso-propanolol above the acceptable concentration limit in affected lots.

What you should do

  • Contact your health care provider to discuss other treatment options, as there are no other companies marketing extended release propranolol in Canada.
  • Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition poses a greater health risk.
  • 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 if you have questions about the recall.
  • 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: 2022-03-02
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-63959