The FDA has been working with B. Braun Medical and other saline solution producers to boost production in the face of a nationwide shortage of the common but essential product. But according to the FDA, the company is continuing to recall more than 1,300 units of its 1,000-mL bags, as well as nearly 54,000 partial additive bags containing 50 mL.
The FDA's most recent weekly Enforcement Report said the products were being recalled because of particulate matter found in retained samples. The FDA tagged the recall with a Class I designation, its most serious, which says that "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." It said the products had been delivered throughout the U.S., Puerto Rico and to Spain, and that it was an ongoing recall that was first initiated in November. The company did not respond to a request for comment.
The agency has been working with Baxter International ($BAX), Hospira ($HSP) and B. Braun for months to boost production since the shortage developed last year. Baxter and Hospira reportedly account for 90% of the production in the U.S. Baxter last year upped its production by 3% and expects to boost it another 9% this year. A Hospira spokesman recently said: "Hospira has been delivering saline throughout the current shortage as well, at historically high levels."
Late last month, the FDA also permitted a Baxter plant in Spain whose product was not approved for use in the U.S. to temporarily send extra capacity here. It made the same accommodation for a Fresenius Kabi plant in Norway. The FDA said the additional capacity would help but not eliminate the shortage. Capt. Valerie Jensen, the associate director for drug shortages at FDA, told CBS radio that with these efforts, the agency expects the situation "to continue to improve, especially with these overseas supplies," but there is no way of knowing when supply will again exceed demand.
- here's one recall notice
- and another
- get the CBS radio report