Every day thousands of Americans rely on the blood thinner Heparin to survive.
Now that drug is under suspicion for 21 deaths and hundreds of allergic reactions. Baxter International, a major manufacturer of the drug, has stopped selling almost all forms of Heparin.
CBS News medical correspondent Dr. Emily Senay reports that officials say they have not yet identified the cause, but are looking to China where nearly half of Heparin's raw ingredients come from.
Until last week, leading manufacturer Changzhou Scientific Protein Laboratories had no operating license and had been completely unregulated, either by Chinese authorities or the Food and Drug Administration, a violation the FDA's own inspection policy.
The FDA finally inspected the plant two weeks ago.
FDA Commissioner Andrew von Eschenbach says that the investigation of the Heparin issue is "active and underway."
The inspection revealed "use of materials from an unacceptable vendor'" and a failure to "identify impurities and deficiencies'" with manufacturing equipment.
Add that to China's year long struggle with pig disease, with pig intestine a primary ingredient in Heparin, and you have a recipe for a pharmaceutical disaster.
"I don't understand why it takes deaths and serious injuries to a large number of Americans before the FDA wakes up this is clearly a wake up call," Dr. Sidney Wolfe of worstpills.org told Senay.
It's a wake up call for Heparin users like Celeste Lee.
Lee, a dialysis patient, has used Heparin as part of her treatment for thirteen years. Like thousands of other users, she is worried about where the drugs are coming from.
"For me it was more of an indication of 'whoa, how are we going…," Lee told Senay. "It's not like we're processing Intel chips or processing micro-processors, we're talking about products for human beings, for human consumption."
The FDA says itself that it is understaffed and underfunded and needs more regulation authority to deal with the growing international outsourcing for the manufacturing of pharmaceuticals.
Senay added that other manufacturers of Heparin have now stepped up production and health officials say that there is unlikely to be a shortage of the drug.