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Thursday, February 26, 2015
Heritage Pharmaceuticals Doing The Right Thing--
Heritage Pharmaceuticals has initiated a nationwide voluntary
recall of ten lots of colistimethate for injection (150 mg) and
three lots of rifampin for injection (600 mg) because of
concerns over lack of sterility.
Colistimethate is indicated for the treatment of acute or
chronic infections due to sensitive strains of certain gram-
Rifampin is indicated for the treatment of all forms of
tuberculosis.The recalled colistimethate has national drug code
(NDC) 23155-193-31, and the recalled rifampin has NDC
Both products are sold in single-vial monocartons in case packs
of ten. The recall (to the user level) stems from observations by
the US Food and Drug Administration (FDA) regarding aseptic
and general manufacturing practices at the manufacturer's site
potentially affecting product sterility, according to a company
news release posted on the FDA website. "Intravenous
administration of nonsterile injection products to a normally
sterile site may result in a site-specific or systemic infection,
which in turn may cause hospitalization, significant morbidity
(permanent organ damage), or fatal outcome. To date, Heritage
is not aware of any adverse patient events resulting from the
use of the subject product lots," the release says.
The recalled products were distributed to hospitals, wholesalers, and distributors nationwide from December 2012 through January 2015 for colistimethate and from October 2014 through January 2015 for rifampin.
Customers are being notified by fax, email, United Parcel Service, and/or certified mail to return all recalled product.
Heritage asks all customers to check their inventory "immediately and to quarantine, discontinue distribution of, and return the recalled lots of product. Customers who may have further distributed these products have been requested to identify their customers and notify them at once of this product recall."
Questions regarding this recall can be directed to the customer call center at (866) 901-1230 Monday through Friday from 9:00 am to 5:00 pm Eastern Standard Time.