Baxter International ($BAX), which has been scrambling to get added supplies of saline to the market in the midst of a national shortage, is having to take a step backward. The Deerfield, IL-based company is recalling one lot of large-volume bags in the U.S. because of contamination.
The drugmaker said Wednesday it was recalling the single lot of 0.9% sodium chloride injection, USP 1000 mL, after particulate matter was found near the administration port in some containers. It is the dosage most affected by the shortage. The company said it has already figured out, and dealt with, the root cause of the particulate, but some of the lot has already been delivered to its customers. If infused, it can cause allergic reactions or worse, like organ damage. So far, no adverse reactions have been reported.
In an emailed statement, Baxter spokesman John O'Malley said, "One lot with 4,000 individual units was distributed among a handful of U.S. customers. Baxter regrets any inconvenience to customers and can assure them that this should have no impact on our efforts to work to meet their needs for saline."
Last month, the drugmaker recalled two lots of 100-mL sodium chloride and one lot of 50-mL product, as well as one lot of 20-mL highly concentrated potassium chloride. They were recalled from Chile, Hong Kong, Singapore and the U.S. O'Malley said at the time that replacement product was available and that the recall of the smaller volume products should not be meaningful to the U.S. supply.
That supply has been in sorry shape all year. The severe saline shortage materialized last year after some product recalls and then a big uptake in use during the last flu season. Saline is a product that hospitals have traditionally turned to millions of times a week, but in the face of the shortage, they have had to rethink their use to make sure they can maintain supplies.
The FDA has been working with Baxter, and the other two U.S suppliers, Hospira ($HSP) and B. Braun Medical, to boost their U.S. production. It has also allowed product to be imported from two European plants that were not approved to ship saline to the U.S., a Fresenius Kabi plant in Norway and a Baxter plant in Spain. But even with those added supplies, the shortage has yet to be overcome.
- here's the recall notice