أدوية ومنتجات صحية
PDP-DIPHENHYDRAMINE 25 MG and 50 MG CAPSULES: Out-of-specification (Impurity)
تفاصيل الاستدعاء أدناه منشورة بالإنجليزية كما أصدرتها الحكومة الكندية دون تعديل. لم تنشر الحكومة صوراً لهذا المنتج.
Summary
| Type | Health product recall |
|---|---|
| Product | PDP-DIPHENHYDRAMINE |
| Issue | Health products - Product quality |
| What to do | Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns. |
| Distribution | National |
| Brand(s) | Pendopharm |
| Last updated | 2026-11-09 |
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot Number |
|---|---|---|---|---|---|
Pendopharm |
PDP-DIPHENHYDRAMINE |
DIN 00757683 |
Capsule |
25 MG |
638997 |
Pendopharm |
PDP-DIPHENHYDRAMINE |
DIN 00757691 |
Capsule |
50 MG |
653809 |
Issue
The impurity, N-Nitroso-N-Desmethyl Diphenhydramine, is out of specification in the affected lots.
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Previous recalls or alerts
Background
Depth of Recall: Retailers
Details
| Original published date | 2026-11-09 |
|---|---|
| Alert / recall type | Health product recall |
| Category | Health products - Drugs |
| Companies | Pendopharm Division of Pharmascience Inc. Montréal, QC H4P 2T4 |
| Published by | Health Canada |
| Audience | General public Healthcare Industry |
| Distribution | National |
| Recall class | Type II |
| Identification number | RA-82928 |
Source: Government of Canada, Recalls and safety alerts – https://recalls-rappels.canada.ca/en/alert-recall/pdp-diphenhydramine-25-mg-and-50-mg-capsules-out-specification-impurity