The recall - which follows the detection of visible particles in Coumadin vials - covers six lots of the injectable produced and distributed to hospital and pharmacies in the US between November 2011 and January 2014
B-MS said the withdrawl was voluntary and added that there have been no product complaints or adverse events reported.
Spokesman Ken Dominski told in-Pharmatechnologist.com the recalled “lots were manufactured for Bristol-Myers Squibb by Pharmalucence, of Bedford, Massachusetts.”
He added that the contract manufacturing organization (CMO) only makes Coumadin for the US market, and suggested that the particulate matter was probably a result of the production process.
“The most probable cause of the metallic-like particles was found to be trays used in the manufacturing process. The most probable cause of the non-metallic cellulose fiber particles was found to be lint-free wipes and autoclave paper used in the manufacturing process.”
The US drugmaker stopped making the injectable form of Coumadin in April (see page 55), however, according to Dominski the decision to cease production was “due to its limited use” rather than any quality problems.
“Coumadin for Injection, for Intravenous (IV) Use is used in rare circumstances and in small percentage compared to the oral form. The IV formulation represents .02% of the total use of Coumadin in the US. The recall is unrelated to the decision to discontinue the product.”
B-MS also sells an oral solid dosage form version of the blood thinner which is not impacted by the recall.