October 31, 2012
Ameridose is conducting 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 shown above. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com.
If you have any Ameridose products on hand, immediately examine your inventory and quarantine products subject to this recall. This recall should be carried out to the user level. Please complete the attached form regarding the current status of these lot(s) and return the form to Ameridose by fax at 508-656-6596, or by email at [email protected].
We then will contact you to arrange for return of all materials. We thank you for your cooperation, and apologize for any inconvenience.
If you have questions regarding this recall, please contact us at 888-820-0622.
Ameridose, LLC 205 Flanders Road, Westborough, MA 01581 Email: [email protected] www.ameridose.com
Ameridose Voluntary Product Recall Response Form
Ameridose Voluntary Product Recall List