BOUCHERVILLE, QC, August 8, 2022 /CNW Telbec/ – JAMP Pharma Corporation (“JAMP“) is voluntarily recalling, as a precautionary measure, one product lot of atorvastatin tablets, 40 mg, size 500 (lot MHC1403A) at retail level (type 1 recall).
On 5 Auguste2022, JAMP initiated with Health Canada a voluntary recall of PrJAMP-Atorvastatin 40mg tablets format 500 (batch MHC1403A) due to possible contamination of the batch by pieces of latex during manufacturing operations.
JAMP takes compliance issues seriously and takes no risks when it comes to patient safety. Therefore, we are recalling the entire batch of PrJAMP-Atorvastatin 40 mg (batch 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 this was an isolated incident involving a piece of 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 disease such as heart attacks.
Risk Statement: There is a risk in using latex on someone who is sensitive or allergic to latex. It is estimated that latex allergy affects 1-2% of the general population. Allergic reactions following contact with latex may be acute or delayed. Latex is derived from the sap of the rubber tree, 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 often, gloves.
JAMP has already informed its wholesalers and distributors and is organizing the returns of the affected lot.
Consumers with questions regarding this recall may contact JAMP Pharma Corporation by calling toll-free at 1-866-399-9091, ext. 501, or by email at [email protected]. Consumers should contact their doctor or health care provider if they have experienced any problems that may be related to taking or using the recalled drug product. Adverse reactions or any other problems encountered with the use of this product may be reported to Health Canada online, using the form available on this website: https://www.canada.ca/en/health-canada/ services/medicaments-health-products/medeffect-canada/adverse-reaction-reporting.html.
About JAMP Pharma Corporation
JAMP Pharma is part of the JAMP Pharma Group, a private Quebec company whose head office is located in Montreal. Having experienced remarkable growth over the past 10 years, the JAMP Pharma Group is present in all segments of the pharmaceutical market, from over-the-counter products to biosimilars. JAMP Pharma has a portfolio of nearly 300 generic molecules and is the Canadian pharmaceutical industry leader in terms of new generic product launches1. It also ranks among the top companies in the country in terms of annual prescription volume.2 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 license from IQVIA Solutions Canada Inc., for the following information service: Canadian Drug Store and Hospital Audit, rolling 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 affiliates or subsidiaries.
2 The pharmaceutical manufacturers with the highest volume of prescriptions reported in Canada from January to August 2021. Based in part on data obtained under license from IQVIA Solutions Canada Inc., regarding 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 affiliates or subsidiaries.
SOURCEJAMP Pharma Corporation
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