JAMP Pharma Corporation ("JAMP") is voluntarily, on a precautionary basis, recalling one product lot of Atorvastatin tablets, 40 mg, 100-format (lot D10776B) at the retail level (type 1 recall).
On August 25th, 2022, JAMP initiated with Health Canada a voluntary recall of JAMP-Atorvastatin 40mg 100-format tablets (lot D10776B) due to a possible mislabeling of certain bottles in the lot, which may be labeled as JAMP-Atorvastatin Calcium 10mg 500-format tablets (DIN 02504197), when they should be labeled as JAMP-Atorvastatin Calcium 40mg, 100-format tablets (DIN 02504219).
JAMP takes compliance matters seriously and takes no chances when it comes to patient safety. This is why, out of an abundance of caution, Jamp is recalling the entire lot of JAMP-Atorvastatin Calcium 40 mg (lot D10776B). An investigation is underway with the manufacturing site to understand the factors that may have led to the current situation. As a result of this investigation, preventive measures and corrective actions will be put in place with the manufacturing site.
Atorvastatin is a prescription drug used to treat high cholesterol and other fats (such as triglycerides) in the blood to prevent cardiovascular diseases, some that can lead to heart attacks.
Risk statement: There is a risk associated with the use of high-dose statins, such as atorvastatin, in patients with predisposing factors for rhabdomyolysis. This risk increases with the concentration of atorvastatin in the body. Therefore, for these patients, a higher than prescribed dose of atorvastatin may increase the risk of developing this medically important condition.
JAMP has already notified its wholesalers and distributors and is arranging the return 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 serviceclient@jamppharma.com. 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.
Source: JAMP Pharma Corporation via PRNewswire