Ben Venue Laboratories, Inc. has temporarily suspended the manufacture and distribution of products produced at its Bedford, OH facility following an internal review that indicated routine maintenance and requalification of some manufacturing equipment did not occur 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,” according to a company statement.  

Ben Venue has notified the global regulatory agencies of the voluntary preventive measure and is assessing stock levels and anticipated demand to minimize impact to product supply in the market place. The FDA has been working with the company to address these issues and help resume manufacturing and distribution of products.

The action impacts the production and release of Johnson & Johnson’s cancer drug Doxil, exacerbating a shortage of the drug that has persisted since the summer.