Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance

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FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Both products are sold in single vial mono-cartons in case packs of ten (10). Heritage has initiated this voluntary recall of Colistimethate for Injection, USP, 150 mg Single-Dose vial and Rifampin for Injection USP, 600 mg Single-Dose vial to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility.

Intravenous administration of non-sterile 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 lot numbers with expiry date being recalled are: Colistimethate for Injection

Lot No.
VCOA002
VCOA003
VCOA004
VCOA005
VCOA006
VCOA007
VCOA008
VCOA009
VCOA010
VCOA011
Exp. Date
9/30/2014
10/31/2014
10/31/2014
1/31/2015
3/31/2015
9/30/2015
12/31/2015
2/29/2016
10/31/2016
10/31/2016

Rifampin for Injection

Lot No.
VRIA002
VRIA003
VRIA004
Exp. Date
8/31/2016
9/30/2016
9/30/2016

The products were distributed to hospitals, wholesalers and distributors nationwide from December 2012 through January 2015 (Colistimethate) and from October 2014 through January 2015 (Rifampin). 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.

About Protak Scientific

I am passionate about making the world a better and safer place hence my focus on bringing the revolutionary Enzyme Indicator technology to the pharmaceutical and medical markets - a way to know decontamination results in seconds, not days. With over 16 years experience in technical, pharmaceutical and scientific sectors, I have a diverse leadership background. I have gained significant experience in, and insight into, pharmaceutical and biotech fields through roles such as Sales Director, Managing Director and CEO, in companies such as Monmouth Scientific, Howorth Air Technology, WH Leary and now Protak Scientific.

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