ACOG/SMFM Update on New England Compounding Center.
The Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention, The Massachusetts Department of Public Health are working together on a multi-state investigation involving a potentially contaminated epidural steroid injection produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts. NECC has also instituted a voluntary recall of all its products from this compounding center. Ob-gyns should be aware that Hydroxyprogesterone caproate 250 mg/ml, distributed in 1ml, 5ml, and 10ml vials are some of the products included on this recall list.
FDA has made the following recommendations for health care providers regarding all products produced by NECC:
- Do not use any product that was produced by NECC at this time
- Retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products
- Follow-up with patients should be done when the following three conditions are met:
- the medication was an injectable product purchased from or produced by NECC,
- the medication was shipped by NECC on or after May 21, 2012, and
- the medication was administered to patients on or after May 21, 2012
FDA continues to provide updated information about NECC on its website including releasing NECC’s customer list: http://www.fda.gov/Drugs/DrugSafety/FungalMeningitis/default.htm.