Pharmascience Inc. voluntarily recalls one lot of pms-Atenolol 100mg due to a labelling error

Starting date:

August 5, 2016

Posting date:

August 5, 2016

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Labelling and Packaging

Audience:

General Public

Identification number:

RA-59716

• Issue
• Products affected
• What you should do
• Who is affected
• Report health or safety concerns
• Media enquiries
• Public enquiries
• What Health Canada is doing
• Images

Issue

Health Canada is advising Canadians that Pharmascience Inc. has initiated a voluntary recall of one lot of pms-Atenolol 100 mg, used to treat cardiovascular conditions such as hypertension (high blood pressure), due to a labelling error. The lot contains foil blister packs incorrectly labelled as pms-Atenolol 50 mg with the wrong Drug Identification Number (DIN). The information on the outer package is correct.

The labelling error could result in a patient taking a double dose of the product. This could result in excessively low blood pressure and decreased heart rate, particularly in elderly patients and patients with impaired kidney function, which may cause dizziness, fainting and falling. Other symptoms could include drowsiness, tiredness, nausea and diarrhea.

Products affected

pms-Atenolol  100 mg (Lot: 495259) expiry May 31, 2017

What you should do

• Users who have in their possession the impacted lot should return the product to their pharmacist.
• Consult with your doctor if you have used this product and have health concerns, or if you have taken a double dose and are feeling unwell.
• Report any adverse  incidents to Health Canada.

Who is affected

Canadians who have used or purchased this product.

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada is monitoring the recall. Should new information become available, Health Canada will take appropriate action and inform Canadians.

Images

Select thumbnail to enlarge - opens in a new window