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:
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-63959
Get notified
Receive notifications for new and updated recalls and alerts by category.