Ameridose Unexpired Products Recalled due to Potential Lack of Sterility

The FDA informs Risk Managers and Healthcare Professionals that Ameridose unexpired products are recalled because there are concerns about a lack of sterility assurance for these products. Use on non-sterile products can lead to life-threatening consequences.

Background of Ameridose Unexpired Products

A complete list of the recalled products by Ameridose LLC can be found at www.ameridose.com.

Products can be identified by markings indicating the company’s name or its logo.

FDA Alert on Ameridose Unexpired Products

The FDA commenced the Ameridose LLC facility inspection as part of the fungal meningitis outbreak investigation. Ameridose and New England Compounding Center (NECC), the company associated with compounded drugs linked to the outbreak, are sharing common management by the same parties.

Preliminary findings raised concerns about a lack of sterility assurance for Ameridose products. Use on non-sterile products can cause a serious hazard to health.

Recommendation on Ameridose Unexpired Products

“At this time, the FDA is recommending that health care professionals do not need to follow up with patients who received Ameridose products. Health care professionals should stop using Ameridose products at this time, and return them to the firm.

Hospitals, clinics, health care professionals, and other customers with Ameridose products on hand should contact Ameridose at 888-820-0622 to obtain instructions on how to return products to Ameridose.

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

Contacting the FDA to report cases with Ameridose Unexpired Products

In case of detection of adverse events or side effects related to the use of Ameridose Unexpired Products, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

AttorneyOne.com is a free nationwide legal referral service. We are not a law firm. We help consumers find the best representation for their legal needs.