Update: October 22, 2012

On October 22, the U.S. Food and Drug Administration posted two inaccurate lists on its website. These two lists were intended to show which customers had purchased which products from the New England Compounding Center since May 2012. However, the information on the lists was incorrect and the FDA has removed the lists from its website. NECC has recalled all products shipped in 2012 and is continuing its efforts to contact all of the customers who received products in 2012 as part of this product recall. Customers are encouraged to complete the recall forms that NECC has sent out to aid in the on-going joint efforts by the FDA and NECC to locate and to secure NECC products. Any customers with questions should contact 1-800-994-6322. In addition, NECC encourages patients to contact their healthcare providers directly if they have questions about medications they have received.

New England Compounding Center Issues
Voluntary Nationwide Recall of All Products

October 6, 2012

New England Compounding Pharmacy, Inc. d/b/a New England Compounding Center (NECC) today announced a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. This action is being taken out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Massachusetts Board of Registration in Pharmacy. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained and secured. While there is no indication at this time of any contamination in other NECC products, this recall is being taken as a precautionary measure. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo that can be accessed here. A complete list of all products subject to this recall can be accessed here.

NECC is notifying its customers of this recall by fax. Clinics, hospitals and healthcare providers that have product which is being recalled should stop using the product immediately, retain and secure the product, and follow instructions contained in the fax notice.

Adverse reactions or quality problems experienced with the use of any product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
   • Online: www.fda.gov/medwatch/report.htm
   • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
   • Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Information for Customers Seeking to Return New England Compounding Center Products