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.