FOR IMMEDIATE RELEASE - October 31, 2012 - Ameridose today announced it will commence a voluntary recall of any unexpired products remaining in circulation. This action is voluntary, and represents an expansion of our cooperation with the U.S.Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy.
During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose's sterility testing process. Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death. Ameridose has not received any adverse reports related to the products subject to this recall and neither Ameridose nor the FDA has identified impurities in any Ameridose products. Nevertheless, out of an abundance of caution, we are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA's recommendations.
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 on-line at www.ameridose.com1. Product was distributed nationwide to healthcare facilities.
Ameridose is notifying its customers by fax and is arranging for return of all recalled products. Customers that have Ameridose products which are all affected by this recall should immediately examine their inventory and quarantine products subject to this recall, complete the form regarding the current status of these products, and return the form to Ameridose by fax at 508-656-6596, or by email at [email protected]. Copies of the recall letter and form are available on the Ameridose website at www.ameridose.com2. A full list of products will be available this afternoon at www.ameridose.com3.
Customers with questions regarding this recall can contact Ameridose by phone at 888-820-0622 on Monday through Friday from 9:00 am to 5:00 pm EST, or by email at [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: http://www.fda.gov/medwatch/report.htm4
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm5. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: FDA at http://www.fda.gov/Safety/Recalls/ucm326349.htm