Mass. firm tied to closed pharmacy issues recall
BOSTON (WCIV/AP) -- A company with the same founders as the specialty pharmacy linked to deadly meningitis outbreak says it's recalling all its products.
In a statement Wednesday, Ameridose said the voluntary recall comes after FDA officials told the company it must improve its sterility testing. The Westborough company says it has no reports of problems with its products, or any impurities, but issued the recall "out of an abundance of caution."
The company did not say how many products it is recalling.
Ameridose agreed to shut down for inspection earlier this month after tainted steroids from the New England Compounding Center were linked to an outbreak that has killed 28.
Ameridose and NECC were both founded by brothers-in-law Barry Cadden and Greg Conigliaro. Ameridose says it is a separate entity with distinct management.
In response to the recall, Charleston area hospitals have been releasing statements regarding the recall.
"Roper St. Francis Healthcare was notified in the evening of Oct. 31 about the precautionary, voluntary recall of Ameridose products. In keeping with our patient safety standards, we immediately began assessing system supplies and pulling those identified as sourced from Ameridose in order to comply with the voluntary recall.
"After a thorough review, RSFH Pharmacies have removed all Ameridose inventory at all of its facilities as of today, Nov. 1, 2012. As no adverse events or tainted product have been reported at this time and FDA officials noted that patient notification is not recommended at this time. Alternative medications for our patients using RSFH pharmacies are already being sought and supplied.
"We assessing how many products were purchased, however, patients should not be concerned as all existing inventory has been eliminated."
"Once Trident Health learned of the voluntary recall, all Ameridose products on hand were immediately sequestered. We have identified alternative sources and expect to have sufficient supplies to meet the needs of our patients."
East Cooper Medical Center's response:
"In response to the FDA's recent announcement regarding a voluntary recall of products compounded by Ameridose, East Cooper Medical Center has sequestered and removed this company's products from our hospital inventory. Patient safety is our top priority. In its announcement, the FDA did not identify any cases of infection or other patient harm associated with these products. The FDA acknowledged that drug shortages may result from this recall, and we are working with the agency and others to identify additional manufacturers as needed."