Ameridose Recalls All Products
Westborough-based Ameridose LLC, the sister company of the Framingham compounding firm tied to a recent meningitis outbreak linked to 28 deaths, today issued a voluntary recall of on all its products.
The company said in a statement that it's chosen to move forward with a recall after the U.S. Food and Drug Administration (FDA) found problems with its sterility testing process during an inspection. The FDA is seeking improvements in the way testing is handled, according to the statement.
"Ameridose and (the) FDA agree that the use of injectable 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," the statement said.
Ameridose instructed consumers who have any of its products to quarantine them and report them to the company. A full list of products subject to the recall is available at www.ameridose.com.
Read more
WBJ Web Partners
Most Recent
Most Recent
0 Comments