B. Braun Medical has voluntarily recalled certain lots of its heparin sodium USP active pharmaceutical ingredient (API) after traces of oversulfated chondroitin sulfate (OSCS) were found in its injection products.
According to B.Braun, seven lots of the heparin products manufactured in 2008 that expire on Oct. 31 and Nov. 30 will voluntarily be recalled. The recalled lots may be found here.
While the company has not received any reports of adverse events associated with the products, B. Braun said that recall is a precautionary measure and is supported by the FDA. The Bethlehem, Pa.-based company issued letters regarding the recalled product and urged users to discontinue the product's use immediately.
Additionally, the company asked healthcare providers who experienced problems to report adverse events to FDA’s MedWatch Adverse Event Reporting program.