JAMP Pharma Corporation issues voluntary recall of one (1) lot of its Atorvastatin tablets, 40 mg, 500-format for lot MHC1403A (Health Canada's Public advisory RA-64446)

BOUCHERVILLE, QC, Aug. 8, 2022 /CNW Telbec/ - JAMP Pharma Corporation ("JAMP") is voluntarily, on a precautionary basis, recalling one product lot of Atorvastatin tablets, 40 mg, 500-format (lot MHC1403A) to the retail level (type 1 recall).

On August 5^th, 2022, JAMP initiated with Health Canada a voluntary recall of ^PrJAMP-Atorvastatin 40mg 500-format tablets (lot MHC1403A) due to a possible contamination of the lot with latex pieces during manufacturing operations. 

JAMP takes compliance issues seriously and takes no chances when it comes to patient safety. Therefore, we recall the entire lot of ^PrJAMP-Atorvastatin 40 mg (lot MHC1403A). A thorough investigation was conducted at the manufacturing site to understand the factors that may have led to the current situation. The investigation concluded that it was an isolated incident involving a piece of a latex glove in a finished product. 

Atorvastatin is a prescription drug used to treat high cholesterol and other fats (such as triglycerides) in the blood and to prevent cardiovascular diseases such as heart attacks.

Risk statement: There is a risk in using latex on an individual who is sensitive or allergic to latex. Latex allergy is estimated to affect 1 to 2% of the general population. Allergic reactions following contact with latex can be acute or delayed. Latex is derived from the rubber tree sap, which is used to make many of the products we use today. Latex is ubiquitous in the healthcare industry, making up much of the equipment used, including catheters, balloons, and most commonly, gloves.

JAMP has already notified its wholesalers and distributors and is arranging the returns of the affected lot.

Consumers with questions regarding this recall can contact JAMP Pharma Corporation by calling toll-free at 1-866-399-9091, extension 501, or by email at [email protected]. Consumers should contact their doctor or healthcare provider if they have experienced any problems that may be related to taking or using the drug product affected by this recall. Adverse reactions or any other issues experienced with the use of this product may be reported to Health Canada online, by using the form found at this website: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html.

JAMP Pharma is part of the JAMP Pharma Group, a privately-owned Québec company headquartered in Montreal. Having enjoyed remarkable growth over the past 10 years, the JAMP Pharma Group is present in all pharmaceutical market segments, from over-the-counter products to biosimilars. JAMP Pharma has a portfolio of nearly 300 generic molecules and leads the Canadian pharmaceutical industry in terms of new generic product launches¹. It also ranks among the country's top companies in terms of annual prescription volume² according to IQVIA. The Group also has a Wampole-Laboratoire Suisse Division with more than 160 over-the-counter products, including a wide range of vitamins, supplements, and natural products, as well as prescription and branded products from its subsidiary Orimed Pharma. The BIOJAMP division recently introduced its first biosimilar product and has the ambition to offer one of the most complete offers on the Canadian market.

¹ Pharmaceutical manufacturers with the highest volume of product launches in Canada from 2016 to 2021. Based in part on data obtained under licence from IQVIA Solutions Canada Inc., concerning the following information service: Canadian Drug Store and Hospital Audit, moving annual total from January to December 2016 to 2021. All Rights Reserved. The statement expressed herein is not necessarily that of IQVIA Solutions Canada Inc. or any of its affiliated or subsidiary entities.

² Pharmaceutical manufacturers with the highest volume of prescriptions reported in Canada from January to August 2021. Based in part on data obtained under licence from IQVIA Solutions Canada Inc., concerning the following information service: CompuScript, January to August 2021. All Rights Reserved. The statement expressed herein is not necessarily that of IQVIA Solutions Canada Inc. or any of its affiliated or subsidiary entities.

SOURCE JAMP Pharma Corporation