The FDA has made two lists of customers shipped potentially contaminated products from the New England Compounding Center (NECC) publicly available on its website. Products under investigation include a cardioplegic solution used in surgery.
This is the second attempt by the FDA to provide a customer list. A list released on Oct. 22 contained technical errors.
Injectable products made by the Framingham, Mass.-based NECC have been linked to an outbreak of meningitis. Follow-up investigations by the FDA found two cases of heart transplant patients who during surgery received a cardioplegic solution produced by the compounder and who later developed fungal infections. FDA also reported that it identified another possible meningitis case potentially associated with epidural injection of a steroid injectable product made by NECC.
The first list posted online includes customer names and addresses, organized by state. The second list contains the same basic information as the first list, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped and the shipping date.
FDA cautioned that the lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and facility information may be incomplete.
On Oct. 4, FDA advised providers to discontinue use of products made by the Framingham, Mass.-based facility. Products manufactured and shipped by NECC on or after May 21, are believed to be of greatest risk of contamination.
The lists are available here.