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FDA MEDWATCH ALERTS

December 18, 2014

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter

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FDA MedWatch Recall - Particulate Matter

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

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FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled

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Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled

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Fungal Meningitis Outbreak: FDA Provides NECC Customer List

Monday, October 22, 2012

[UPDATE 10/22/2012] FDA is making available two lists of customers (consignees) who received products that were shipped on or after May 21, 2012 from New England Compounding Center’s Framingham, MA facility. The first list 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. 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. Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012.

FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditions are met:

  • The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution,
  • 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.

Since the May 21, 2012 date is the date the first of three lots of methylprednisolone acetate implicated in the current outbreak was produced, products produced and shipped by NECC on or after May 21, 2012 are believed at this time to be of greatest risk of contamination. Now that we have shipping information available, we are updating FDA’s recommendation to health care providers so that they can focus their attention on following up with the patients who are believed to be at greatest risk of receiving a contaminated product.

Read the MedWatch Safety Alert, including links to the FDA update and the NECC Customer Lists, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm

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