Ben Venue Legacy Issues Prompts Voluntary Recall of Two Lots of Cancer Drug

Ben Venue Laboratories is voluntarily recalling 7,172 vials of the anticancer drug, CYTARAbine for Injection USP, in lyophilized glass vials, 1 gram per vial, according to the US Food and Drug Administration’s (FDA) Weekly Enforcement report of August 27, 2014. The product was distributed by Bedford Laboratories of Bedford Ohio, and manufactured by Ben Venue, also of Bedford. The voluntary Class II recall was initiated on July 31, 2014 due to concerns over a lack of assurance due to crimp defects during visual inspection that could affect container-closure integrity. The recall applied to two lots with respective expiration dates of July 2014 and August 2014.

In mid-July 2014, Hikma Pharmaceuticals completed its previously announced acquisition of Bedford Laboratories from Boehringer Ingelheim in a move to enhance it position in the US generic injectables market. In late July 2014, Hikma agreed to acquire substantially all of the assets of the generic injectables manufacturing site of Ben Venue in Bedford, Ohio, from Boehringer Ingelheim, as part of a related arrangement with respect to the Bedford Laboratories acquisition.

All manufacturing at the Ben Venue site ceased in December 2013. In January 2013, Ben Venue Laboratories voluntarily entered into a consent decree with the FDA over GMP violations, which followed the company’s decision to voluntary suspend manufacturing in November 2011. Ben Venue invested more than $350 million to upgrade the facility, but announced in October 2013 that it would end manufacturing by the end of 2013. In August 2011, Ben Venue announced it was exiting the contract manufacturing market, but continued to make product for Bedford Laboratories.

The Ben Venue manufacturing site includes four manufacturing plants and a Quality and Development Center, which includes a R&D pilot plant. At the time of the agreement to acquire Ben Venue in July 2014, Hikma said it will evaluate over time the potential to partially reactivate the site, and in the short term, transfer certain advanced equipment, including lyophilizers and filling lines, to its other Hikma manufacturing facilities in the US and Europe.

A Class II recall  is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Source: FDA

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