Frequently Asked Questions: Ameridose Recall

Background

On October 31, 2012, the Food and Drug Administration (FDA) announced that Ameridose is voluntarily recalling of all 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) in Massachusetts. NECC is the firm that distributed and recalled injectable steroid medications implicated in the ongoing multistate outbreak of fungal meningitis and other infections.¹

• CDC and FDA are not aware of any recent reports of infections associated with Ameridose products. However, the preliminary results of FDA's inspection of Ameridose have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations starting on October 10.
• CDC's communications about the ongoing multistate outbreak of fungal meningitis and joint infections can be found at: www.cdc.gov/hai/outbreaks/meningitis.html.

Is the current Ameridose recall connected to the multistate outbreak of fungal meningitis and other infections?

• No, there is not a direct link between the Ameridose recall and the ongoing outbreak of fungal meningitis and other infections. Ameridose is managed by some of the same people as the New England Compounding Center (NECC) in Massachusetts. NECC is the firm that distributed and recalled injectable steroid medications implicated in the current multistate outbreak of fungal meningitis.
• The Ameridose recall is based on preliminary results of FDA's ongoing inspection, which has raised concerns about the lack of sterility assurance for the products produced at and distributed by Ameridose.
• To date, there is no evidence that this lack of sterility assurance has resulted in any confirmed reports of infections. Therefore, FDA does not urge direct patient follow-up at this time.

What should healthcare providers do who have Ameridose products?

• Healthcare professionals should stop using and return to Ameridose all Ameridose products at this time, and report any infections associated with Ameridose products to FDA's MedWatch. 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.

Should healthcare providers follow-up with patients who have received Ameridose products?

• At this time CDC and FDA are not urging healthcare professionals to follow-up with patients who received Ameridose products. FDA is not aware of reports of any infections associated with Ameridose products. However, clinicians should remain vigilant, and report to FDA's MedWatch any infection or adverse events believed to be associated with use of a product from Ameridose.

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What should I do if I have a patient who has received an Ameridose product and has an adverse event?

• Clinicians should report any infection or adverse events believed to be associated with use of a product from Ameridose to 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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How will drug availability be impacted by the recall?

• FDA has identified some Ameridose products that currently are on the critical drug shortage list. These products were in shortage before the Ameridose recall, but supplies may be further affected as a result of the Ameridose recall. FDA is taking a number of actions, including working with alternative manufacturers of approved products to maintain supplies of these life-saving drugs.

What should I do if I believe there is a drug in shortage?

• Clinicians should refer to the FDA's Drug Shortage website for information on availability of drugs currently in shortage. If you believe there is a drug entering shortage, please notify FDA's Drug Shortage Team at drugshortages@fda.hhs.gov.

For Patients

What should patients do if they are concerned about what product was used in their healthcare procedure?

• If you are concerned about which product was used in your procedure, you should contact the physician who performed your procedure.

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¹NECC 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