Current good manufacturing practice deficiencies. Duramed Pharmaceuticals, Inc., Cincinnati, Ohio. Firm-initiated recall ongoing. Product fails USP dissolution test. Firm-initiated recall complete.
Firm estimates none remains on market.
Firm-initiated recall complete. Blood products, collected into blood bags, possibly adulterated with particulate matter, were distributed. GE Medical Systems, General Electric Company, Milwaukee, Wisconsin. FDA approved the firm's corrective action plan October 4, 1990. Firm-initiated field correction ongoing.