Heritage Pharmaceuticals Issues Product Safety Warning Due to Reported Sales of Counterfeit Drug Product Labeled as BiCNU® (Carmustine for Injection) 100mg Outside of the United States
EATONTOWN, N.J., April 29, 2016 /PRNewswire/ -- Heritage Pharmaceuticals Inc. ("Heritage") today announced that it recently became aware of the existence of a counterfeit drug product labeled as BiCNU® (Carmustine for Injection) 100mg that has been sold and distributed outside of the United States.
BiCNU® is primarily used for chemotherapy in the treatment of several types of brain cancer, multiple myeloma and lymphoma (Hodgkin's and non-Hodgkin). BiCNU® is also sometimes used for immunosuppression before organ transplantation or hematological stem cell transplantation, a type of bone marrow transplant, in order to reduce the white blood cell count in the recipient.
To the best of Heritage's knowledge, the counterfeit product has only been found in distribution in countries outside the United States - including India, Ireland and Israel. However, because Heritage takes the issue of counterfeiting this BiCNU® product very seriously, Heritage is consulting with the U.S. Food and Drug Administration ("FDA") to aid their evaluations, assist with determining the source of the counterfeit drug, and prevent the further distribution of this product or its introduction into the United States.
Heritage has directly notified all customers of this product along with providing detailed information that will help identify a counterfeit BiCNU® product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return any suspected counterfeit product. Any customers who may have recently distributed the BiCNU® products to its own customers have been requested to convey this information to their customers, healthcare professionals, and any others who use the BiCNU® product, so they will be able to carefully examine all BiCNU® products before use and to identify the characteristics of a suspected counterfeit product.
Anyone who has questions, or needs additional information concerning this matter should contact the Heritage customer call center directly at (866) 901-3784 M-F 9am-5pm EST.
Any health practitioner customers, who determine that they are in possession of a counterfeit product, should contact the FDA through MedWatch, and instructions for such reporting are available at http://www.fda.gov/drugs/drugsafety/ucm170314.htm.
Any end user customers, who believe they may have received a counterfeit drug, should return the product to the pharmacy that dispensed the medicine.
Additional information about this counterfeit product can be found at: www.heritagepharma.com.
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SOURCE Heritage Pharmaceuticals Inc.