"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the FDA's Office of Manufacturing and Product Quality, said during an Oct. 26 news conference.
In addition, the company couldn't prove that the equipment used to sterilize these products was actually able to sterilize them, Lynn said.
The FDA also found that the company wasn't able to keep its "clean room" clean, Lynn said. "A clean room is a space designed to maintain a controlled environment with low levels of airborne particles and surface contamination," he explained.
The U.S. Centers for Disease Control and Prevention on Friday had the following state-by-state breakdown of cases: Florida: 23 cases, including 3 deaths; Georgia, 1 case; Idaho, 1 case; Illinois, 2 cases; Indiana: 52 cases, including 4 deaths; Maryland: 23 cases, including 1 death; Michigan: 128 cases, including 7 deaths; Minnesota: 11 cases; New Hampshire: 13 cases; New Jersey: 27 cases; New York: 1 case; North Carolina: 3 cases, including 1 death; Ohio: 16 cases; Pennsylvania: 1 case; Rhode Island: 3 cases; South Carolina: 1 case; Tennessee: 81 cases, including 13 deaths; Texas: 2 cases; Virginia: 50 cases, including 2 deaths.
Ten of the 438 cases involve what the CDC calls "peripheral joint infection," meaning an infection in a knee, hip, shoulder or elbow. These joint infections aren't considered as dangerous as injections near the spine for back pain that have been li
All rights reserved