Colistimethate, Rifampin Recalled Due to Sterility Concerns

Megan Brooks

Disclosures

February 25, 2015

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-negative bacteria. 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 23155-340-31.

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 lot numbers and expiration dates for the recalled colistimethate for injection are as follows:

VCOA003 Oct 31, 2014
VCOA004 Oct 31, 2014
VCOA005 Jan 31, 2015
VCOA006 Mar 31, 2015
VCOA007 Sep 30, 2015
VCOA008 Dec 31, 2015
VCOA009 Feb 29, 2016
VCOA010 Oct 31, 2016
VCOA011 Oct 31, 2016

 

The lot numbers and expiration dates for the recalled rifampin for injection are as follows:

Lot No Exp. Date
VRIA002 Aug 31, 2016
VRIA003 Sep 30, 2016
VRIA004 Sep 30, 2016

 

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.

Adverse reactions or quality problems experienced with the use of these products should be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch- online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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