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Nationwide Recall of All NECC Products and FDA "Do Not Use" Advisory


As of October 18, 2012, 257 cases of fungal meningitis in 16 states have been reported to the CDC, including 20 deaths.

 

On Oct., 15, as a result of the FDA, CDC, and state health departments’ ongoing investigation of contamination at the New England Compounding Center’s (NECC) Framingham, Massachusetts facility (as previously reported to you in Scalpel Weekly News), the FDA advised providers to not use any NECC products. A complete list of all products subject to this recall can be accessed at the link below. At this point in the FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern.

 

The CDC continues to confirm the presence of the fungus Exserohilum in clinical specimens from people with meningitis. At this time, only one clinical specimen has tested positive for the fungus Aspergillus.

 

The following disease cases have resulted:

 

  • Meningitis of unknown etiology following epidural or para-spinal injection after May 21, 2012.

 

  • Posterior circulation stroke without a cardioembolic source and without documentation of a normal cerebrospinal fluid (CSF) profile, following epidural or para-spinal injection after May 21, 2012.

 

  • Osteomyelitis or abscess of unknown etiology in the spinal or para-spinal structures at the site of injection following epidural or para-spinal injection after May 21, 2012. 

 

  • Osteomyelitis or worsening inflammatory arthritis of a peripheral joint (e.g., knee, shoulder, or ankle) of unknown etiology diagnosed following joint injection after May 21, 2012. 

 

Clinicians should continue to contact patients who have received medicines associated with the following three lots of preservative-free methylprednisolone acetate (80mg/ml) from the New England Compounding Center (NECC) that were recalled (reported to you in the Oct. 15 Scalpel Weekly News).

 

 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

 

The potentially contaminated injections were given starting May 21, 2012.

 

Based on the business relationship between New England Compounding Center (NECC) and Ameridose, the FDA and the Massachusetts Board of Pharmacy launched a joint inspection at the Ameridose facility in Westborough, Massachusetts. The FDA is investigating whether certain aspects of compounding practices and facility conditions observed at NECC may be present at the Ameridose facility. The FDA will review whether Ameridose has procedures and facilities necessary to safely produce and provide sterile drug products. At this time, there is no known contamination of products produced by Ameridose.

 

Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop. In this outbreak, symptoms typically have appeared one to four weeks following injection, but it is important to know that longer and shorter periods of time between injection and onset of symptoms have been reported. Therefore, patients and physicians need to closely watch for symptoms for at least several months following the injection.

 

See the CDC Report

 

See the FDA Statement

 

See the Original Recall

 

 

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