Published October 10, 2012
The pharmacy responsible for manufacturing contaminated steroid shots suspected in a meningitis outbreak, which has killed 12 and sickened more than 120 around the U.S., has set up a recall operations center to properly remove its products from circulation.
Since the September 25 recall of three lots of a steroid produced by the New England Compounding Center (NECC), the outbreak has spread to 10 states and infected 137 people, according to state health departments and the Centers for Disease Control and Prevention
Brad Puffer, director of communications for the office of Massachusetts Attorney General Martha Coakley, said he could not "confirm or deny" a criminal investigation into the company.
Also of interest – one of the NECC’s owners, Sophia Pasedis, also owns a related pharmacy nearby; one of its executives is a board member and former president of the state agency that regulates pharmacies.
The Boston Globe reported that Sophia Pasedis was appointed to the 11-member Massachusetts Board of Registration in Pharmacy in both 2004 and 2008. She also serves as the vice president of regulatory affairs and compliance at Ameridose in Westborough – which has the same ownership as the Framingham-based NECC.
The state Public Health Department, which oversees the pharmacy board, said Pasedis has recused herself from all matters on Ameridose and New England Compounding.
Back in 2008, Ameridose was forced to recall a powerful painkiller because it was deemed too potent.
The NECC issued a recall of all its products on October 6 as a precautionary measure, although it maintains there is no cause for concern regarding other products. The U.S. Food and Drug Administration and CDC, along with the Massachusetts Board of Registration in Pharmacy, are investigating NECC.
The company said in its press release it is working closely with these agencies to determine the source of infection in the steroid injections.
The outbreak is raising pressure for stricter oversight of a largely unregulated corner of the pharmaceutical world.
For more information and a list of states and facilities affected by this recall, visit http://www.cdc.gov/HAI/outbreaks/meningitis.html.
You can also visit the pharmacy's website at http://www.neccrx.com, where you can find a full list of recalled products.
Any adverse reactions or quality problems associated with the company's products should be reported to the FDA's MedWatch Adverse Event Reporting program.
The Associated Press and Reuters contributed to this report.