WEDNESDAY, OCTOBER 31, 2012
AMERIDOSE INSTITUTES RECALL OF ALL PRODUCTS: Ameridose,
which holds out-of-state pharmacy permits #10410 and #10411, announced today
that it is recalling
all products. Ameridose is affiliated by ownership
with New England Compounding Center, whose permit was summarily suspended by the
Board of Pharmacy on October 3, 2012. Ameridose ceased operations in early
October pending inspections by the Massachusetts Board of Pharmacy and the Food
and Drug Administration. According to press reports, FDA has reported potential
problems with sterility control at the Ameridose facility. More information may
be found here:
http://www.boston.com/whitecoatnotes/2012/10/31/ameridose-recalls-all-drugs-after-fda-finds-problems-with-its-sterility-testing/Yno31L2Aw7LeAjOElo0DnO/story.html
Reports state that no Ameridose product has been linked to a patient injury
or illness. The recall is being instituted as a precautionary measure.
Forms and instructions for any health-care facility who has Ameridose products
in its inventory may be found here:
http://www.ameridose.com/news/.
Ameridose will be notifying each facility to which it has shipped
products of the recall by fax. ALL HEALTH CARE FACILITIES IN NORTH
CAROLINA ARE URGED TO DETERMINE IF THEY HAVE ANY AMERIDOSE PRODUCTS IN THEIR
STOCK AND RETURN THOSE PRODUCTS AS DIRECTED IN THE LINKED INSTRUCTIONS. Board
staff will communicate further information to pharmacists and health-care
providers as it becomes available.
UPDATE: On November 1, 2012, the Board of Pharmacy
summarily suspended out-of-state pharmacy permits 10410 and 10411 held by
Ameridose, 201 and 205 Flanders Road, Westborough, Massachusetts. The
suspension orders may be found here: