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U.S. Department of Health and Human Services

Drugs

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Advice to Healthcare Professionals

FDA advises healthcare professionals to follow-up with patients who have been administered an injectable product shipped by NECC on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution.  FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories, or for patients who may have received an NECC product in these categories before May 21, 2012.  Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date.  FDA is not recommending that healthcare providers follow-up with these patients unless they have reported symptoms of infection.

Health care professionals should retain and secure all remaining products purchased from NECC.  All NECC products are subject to voluntary recall.  Clinics or customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.

Clinicians and patients are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch.

Healthcare professionals and patients may dial FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.

If you have identified NECC customers who received product that do not appear on these lists, please contact FDA’s Drug Information Line to report this problem.

FDA continues its investigation and may issue additional public communications as appropriate.