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Ben Venue Laboratories, Inc, (“Ben Venue”) has voluntarily and temporarily suspended manufacture and distribution of products produced in its Bedford, OH facility.
A recent internal review of documentation indicated that routine preventive maintenance and requalification of some manufacturing equipment did not occur at the specified time interval, and is overdue. To uphold our commitment to quality and product safety, Ben Venue is completing a site-wide assessment in order to fully understand the potential impact, if any, and implement any appropriate corrective actions that may be needed as quickly as possible to ensure that healthcare providers and patients have access to the medicines they need.
Ben Venue has notified the global regulatory agencies of this voluntary preventive measure and is assessing stock levels and anticipated demand to minimize impact to product supply in the market place. The U.S. Food and Drug Administration has been and will continue to work closely with Ben Venue to address these issues and help resume manufacturing and distribution of products as soon as possible.
Ben Venue is committed to providing pharmaceutical products that improve the health and quality of life of patients. As a provider of many medically-necessary drugs, including several products for which we are the sole-source manufacturer, we recognize the importance of ensuring that healthcare professionals and patients have access to the products they need, when they need them, with the highest attention to quality and product safety.
Questions regarding this notice can be directed to our Bedford Laboratories Customer Service Center at 1.800.562.4797 - Monday – Friday, 8am – 5pm EST.