PDP-DIPHENHYDRAMINE 25 MG CAPSULE: Out-of-specification (Impurity)
Brand(s)
Last updated
Summary
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
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot Number |
|---|---|---|---|---|---|
Pendopharm |
PDP-DIPHENHYDRAMINE |
DIN 00757683 |
Capsule |
25 MG |
642913 |
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.
Additional information
Background
Depth of Recall: Retailers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Pendopharm Division of Pharmascience Inc.
6111 avenue Royalmount suite 100,
Montréal, QC H4P 2T4
Published by
Health Canada
Audience
General public
Healthcare
Industry
Distribution
National
Recall class
Type II
Identification number
RA-82720
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