Baxter International ($BAX) has initiated a worldwide recall of three lots of sodium chloride as well as one of highly concentrated potassium chloride, the company announced today. The recall of the saline comes even as hospitals for months have been facing a shortage of the essential product.
The intravenous (IV) solutions are being recalled to the hospital level after four customers complained that they found bags that contained particulate matter, which has been an ongoing problem for Baxter IV products. The notice of the recall issued by the FDA says there have been no adverse reactions reported so far. But there are risks if someone gets a solution with particulates in it. During a March recall of a single lot of a dialysis product in which mold was found, the drugmaker acknowledged that there had been reports of reactions after patients received the solution.
Baxter spokesman John O'Malley said in a statement today that, "The products affected by this recall are smaller volume IV solutions, not the large volume containers that have seen the greatest constraint in supply in the U.S. As such there should be no impact in Baxter's continuing effort to meet patient and customer needs for 0.9% Sodium Chloride Injection. Specific to the smaller volume IV solutions that are being recalled, replacement product is available for order." He said the four lots were recalled from Chile, Hong Kong, Singapore and the U.S.
The severe saline shortage materialized after some product recalls last year and then a surge of use during the last flu season. It has forced producers to sometimes to limit shipments and many U.S. hospitals to rethink their use to make sure they can maintain supplies of the essential treatment. It is a product that the U.S. system turns to millions of times a week.
The FDA has been working with the three U.S. manufacturers, Baxter, Hospira ($HSP) and B. Braun Medical, to boost their U.S. production and even allowed the import of product from two European plants that were not approved to ship saline to the U.S. In March, the FDA temporarily approved a Fresenius Kabi plant in Norway to ship to the U.S. and a couple of weeks later made the same concession for a Baxter plant in Spain. Even with those additional supplies, the shortage has not yet been resolved.
- read the recall notice