Public Advisory - Recall of one lot of Jamp-Atorvastatin Calcium as some bottles may be labelled as containing 10 mg tablets, but contain 40 mg tablets

OTTAWA, ON, Aug. 27, 2022 /CNW/ -

Summary

• Product: Jamp-Atorvastatin Calcium. Some bottles may be labelled as 10 mg tablets (DIN 02504197) but contain 40 mg tablets. 
• Issue:  Health products – Dosage
               Health products – Labelling
• What to do: Check your bottle of Jamp-Atorvastatin Calcium, 10 mg tablets to make sure it contains 10 mg tablets and not 40 mg tablets. If you are unsure, contact your pharmacist to check if your bottle contains the correct tablets. If you see incorrect tablets, stop taking the medication and contact your pharmacy immediately for a replacement product. Seek immediate medical attention if you experience serious adverse effects, which may include muscle pain or muscle weakness.

Photos

Affected products

Issue

Jamp Pharma Corporation is recalling one lot (D10776B) of Jamp-Atorvastatin Calcium after one bottle labelled to contain 10 mg tablets of Jamp-Atorvastatin Calcium was found to contain 40 mg tablets of Jamp-Atorvastatin Calcium.

Pharmacists may not recognize the error and accidentally repackage and dispense bottles to patients that are labelled as 10 mg atorvastatin calcium tablets (DIN 02504197), but incorrectly contain 40 mg atorvastatin calcium tablets.

Product from the affected lot was sold to pharmacies between May 2022 and August 2022.

Both the 10 mg and 40 mg atorvastatin calcium tablets are similar-looking white and oval shaped tablets; however, the 10 mg tablets have a "10" marked on one side while the 40 mg tablets have a "40" marked on one side. 

Atorvastatin calcium is a prescription drug in the class of statins used to lower cholesterol and other fats in the blood and for prevention of cardiovascular disease such as heart attacks.

Taking too much atorvastatin calcium or more than the prescribed amount for a long period of time (i.e., taking 40 mg of atorvastatin calcium instead of 10 mg atorvastatin calcium) can increase the risk of serious adverse events, including muscle pain or muscle weakness (i.e., rhabdomyolysis, a rare but serious adverse event associated with statins).

The Department is monitoring the company's recall and will inform the public if any new health risks are identified.

What you should do

• Check your bottle of Jamp-Atorvastatin Calcium, 10 mg tablets to make sure it contains 10 mg tablets and not 40 mg tablets. 10 mg atorvastatin calcium tablets are white to off-white, oval shaped, film-coated tablets, with "10" marked on one side and "AT" marked on the other. 40 mg atorvastatin calcium tablets are white to off-white, oval shaped, film-coated tablets, with "40" marked on one side and "AT" marked on the other.
• If you are unsure, contact your pharmacist to check if your bottle of Jamp-Atorvastatin Calcium contains the correct tablets.
• If you see incorrect tablets, stop taking the medication and contact your pharmacy immediately for a replacement product. Return the affected product to your pharmacy for proper disposal.
• Seek medical attention immediately if you experience any serious adverse effects from atorvastatin calcium which may include muscle pain or muscle weakness.
• Contact Jamp Pharma Corporation by calling toll-free at 1-866-399-9091, extension 501, or by email at serviceclient@jamppharma.com, if you have questions about this recall.
• Report any health product adverse events or complaints to Health Canada.

Additional information for health care professionals:

• Health care professionals, such as pharmacists, should check bottles labelled as Jamp-Atorvastatin Calcium, 10 mg tablets before dispensing to ensure they contain the correct tablets.
• Report any unusual packages to the company, and to Health Canada.

Alert / recall type: Public Advisory
Category: Health products – Drugs
Published by: Health Canada

Également disponible en français

SOURCE Health Canada

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