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-

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 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.