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Safety

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial Due to a Lack of Sterility Assurance

Contact:
Consumer:
1-800-505-9291

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.

Customers are being notified by fax, email, UPS, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine 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.

Any questions about returning unused product should be directed to the customer call center at (866) 901-1230 M-F 9am-5pm EST. Healthcare workers who have medical questions about Colistimethate for Injection, USP, 150 mg base/vial and Rifampin for Injection USP, 600 mg/vial may contact Heritage Medical Affairs (732-429-1000, Ext. 101) M-F 9am-5pm EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Report Program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Heritage Pharmaceuticals Inc.

Heritage Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development, licensing, sales and marketing of prescription pharmaceutical products.

CUSTOMER SUPPORT:
Customer Service:
Toll free: 1-800-505-9291

HERITAGE SCIENTIFIC AFFAIRS:
Dr. Pablo Davila
(732) 429-1000, Ext. 101

Source: Heritage Pharmaceuticals Inc.

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Page Last Updated: 02/25/2015
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