BETHESDA, MD 04 September 2012—The discovery of a BiCNU vial containing more carmustine than the label declares prompted distributor Bristol-Myers Squibb Company last week to recall 10 lots of the cancer treatment made by a former third-party contract manufacturer.
In a letter (PDF) dated August 29, Bristol-Myers Squibb said the carmustine lots were manufactured by BenVenue Laboratories and distributed between March 2010 and July 2011.
Each package of BiCNU is supposed to contain a vial with 100 mg of carmustine and an ampul with 3 mL of diluent. The BiCNU lots being recalled have a carmustine vial or diluent ampul with an expiration date as soon as November 2012 or as late as April 2014.
Bristol-Myers Squibb said the problematic vial was discovered at the manufacturing facility during a stability test.
Ben Venue's facility in Bedford, Ohio, has had troubles for several years. FDA inspectors in 2007 reported "significant deviations" from the current good manufacturing practice regulations. Problems persisted, and the company announced in August 2011 that it was exiting the contract manufacturing business and focusing on its Bedford Laboratories generic injectable business.
That same month Bristol-Myers Squibb obtained FDA's approval to have Emcure Pharmaceuticals Ltd. of India manufacture the carmustine component of BiCNU.
Bristol-Myers Squibb said it does expect the recall to result in a shortage.