FDA Recalls 17,000 Vials of Possibly Contaminated Blood Product
Sep. 27, 1996
WASHINGTON (AP) _ A Pennsylvania company is recalling 17,000 vials of human albumin, a blood product commonly used in dialysis treatment because it appears contaminated with dangerous bacteria.
The Food and Drug Administration has learned of two patients, one in Kansas and one in Wisconsin, who survived cases of blood poisoning after receiving the albumin, sold under the brand name Albuminar.
Only one lot of the albumin _ lot P61205 _ is contaminated and being recalled, said manufacturer Centeon, of King of Prussia, Pa.
Centeon is investigating how the albumin could have been tainted with the bacterium Enterobacter cloacae, a bug commonly spread through fecal contamination in water.
The lot was distributed in June, but Centeon began withdrawing it from hospitals on Sept. 20. Friday, the FDA declared the recall its highest priority, Class I, and publicized it in case hospitals or distributors missed the company's withdrawal.
While the blood poisoning can send patients into shock or kidney failure and eventually kill them _ in worst cases within hours _ it can be treated successfully with antibiotics, said Dr. Jay Epstein, FDA biologics chief.
Symptoms include a high fever that spikes rapidly, shaking chills and an abrupt drop in blood pressure.
For more information, Centeon can be reached at 800-504-5434.