Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance
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
Rifampin for Injection
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.
- The Shortfalls Of Biological Indicators For HPV Decontamination Validation - 7th Sep 2017
- Global Exclusive License Signed - 23rd May 2017
- The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products - 23rd May 2017
- Protak trials with Public Health England in 2015 - 23rd May 2017
- Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control - 23rd May 2017
- Hospira Issues a Voluntary Recall Due to Mold Contamination - 23rd May 2017
- Applications Of Enzyme Indicators Versus Biological Indicators - 23rd May 2017
- Phillip Godden CEO, On Protak, His Passion And Why Enzyme Indicators Are The Future - 23rd May 2017
- The Real Value Of Using Enzyme Indicators For Decontamination Validation - 23rd May 2017
- FDA alert – Voluntary Recall – Potential Impact on Product Sterility - 23rd May 2017