B. Braun Medical has issued a recall of heparin in the U.S. and Canada after the company was notified by its supplier that it had acquired a contaminated lot of the drug.
Scientific Protein Laboratories (SPL), which supplies B. Braun Medical with the heparin active pharmaceutical ingredient, notified B. Braun.
B. Braun Medical began recalling 23 lots of finished product on March 21. To date, neither the company nor the FDA has received any reports of adverse events related to their product.
Patient safety remains SPL's paramount concern. SPL has been working aggressively with the FDA and Baxter, as well as with outside experts, to identify the root cause of the adverse events seen in Baxter products. Thus far, no conclusions have been reached about the root cause. It is premature to conclude that the heparin active pharmaceutical ingredient (API) sourced from China and provided by SPL to Baxter is responsible for these adverse events.
Baxter International, which supplies about half the U.S. demand for heparin, recalled last month all its multi- and single-dose vials of heparin sodium for injection after initial reports of allergic reactions and deaths were connected to the product. As a precautionary measure, Baxter also recalled its heparin lock flush products.
The FDA last week announced it identified the contaminant in heparin as oversulphated chondroitin sulfate, a dietary supplement made from animal cartilage and used to treat joint pain. The chondroitin sulfate was chemically altered to act like heparin, making it difficult to identify using standard quality testing methods.
FDA officials have determined the contaminant was introduced in China, where crude heparin is made for export to the U.S. The FDA did not say whether the contaminant was intentionally or accidentally put into the crude heparin.