CDC is aware that New England Compounding Center has voluntarily expanded its recall to include all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts.
CDC's guidance to patients has not changed as a result of this voluntary recall. Patients who feel ill and are concerned about whether they received a medication from NECC should contact their physicians.
Clinicians should actively contact patients who have received medicines associated with three lots of preservative-free methylprednisolone acetate (80mg/ml) recalled on September 26. The potentially contaminated injections were given starting May 21, 2012. Symptoms that should prompt diagnostic evaluation include: fever, new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling of the injection site.
Product Recall
On September 25, 2012, the New England Compounding Center located in Framingham, MA voluntarily recalled the following lots of methylprednisolone acetate (PF) 80mg/ml:
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013
All infections detected as of October 8 have occurred after injections with methylprednisolone acetate products from one of these lots. At this time, there is no evidence of infection related to other NECC products.
The FDA investigation into the NECC facility is ongoing. On October 5, FDA reported observing “fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from the New England Compounding Center.” Further analysis is ongoing. On October 6, NECC expanded its previous recalls to include all products currently in circulation that were compounded at and distributed from its facility in Framingham, Mass. More information about this recall is available at the FDA website.
Recommendations
Physicians should contact (by phone or in person) any patient who had an injection (e.g., spinal, joint) after May 21, 2012, using any of the following three recalled lots of preservative-free methylprednisolone acetate (80mg/ml) produced by NECC, to determine if they are having symptoms:
Methylprednisolone Acetate (PF) 80mg/ml Injection, Lot# 05212012@68, BUD 11/17/2012
Methylprednisolone Acetate (PF) 80mg/ml Injection, Lot#06292012@26, BUD 12/26/2012
Methylprednisolone Acetate (PF) 80mg/ml Injection, Lot# 08102012@51, BUD 2/6/2013
Symptoms that should prompt diagnostic evaluation include: fever, new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling at injection site. Some of the symptoms of patients who have ultimately been diagnosed with meningitis have been mild and not classic for meningitis (e.g., new or worsening headache without fever or neck stiffness).
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