Information About Voluntary Recall of All Ameridose Medical Products

FDA Updates

On October 31, 2012, the Food and Drug Administration (FDA) announced that Ameridose is voluntarily recalling all of its unexpired medical products in circulation. Ameridose is based in Westborough, Mass., and is managed by some of the same people as the New England Compounding Center (NECC), the firm that distributed and recalled injectable medications implicated in the ongoing multistate outbreak of fungal meningitis and other infections. NECC later recalled all medications at its compounding center and has reported laboratory findings of bacterial contamination.

Information on this site is focused on the Ameridose recall.

Background

The recall of Ameridose products is different from the recent recalls of NECC products. The Centers for Disease Control and Prevention (CDC) and FDA are not aware of any recent reports of any infections associated with Ameridose products, unlike the three lots of preservative-free methylprednisolone acetate (MPA) from NECC that were recalled on September 26 and directly linked to cases of fungal meningitis and joint infections. Therefore, at this time, FDA does not urge healthcare professionals to follow-up directly with patients who received Ameridose products.

Advice to Clinicians

CDC and FDA are advising health care professionals to stop using and isolate for return to Ameridose all Ameridose products. Hospitals, clinics, health care professionals, and other customers with product on hand should contact Ameridose at 1-888-820-0622 to obtain instructions on how to return products to Ameridose.
Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo. A complete list of all products subject to this recall can be accessed online at www.ameridose.com.
At this time CDC and FDA do not urge direct patient follow-up for Ameridose products. However, clinicians should remain vigilant to the possibility of infections associated with the use of Ameridose products, and report to FDA’s MedWatch any infection or adverse events identified in a patient known to have received a product from Ameridose.
Contact FDA’s MedWatch Program by fax at 1-800-FDA-0178 (or 1-800-332-0178); by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch.

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