In Brief: Miles
Miles: Company begins worldwide withdrawal of certain lots of five intramuscular immunoglobulin products that were manufactured and released prior to the advent of testing for the hepatitis C virus. The products being withdrawn are Gamastan (immune globulin, USP), Hyper-Tet (tetanus immune globulin), Hyperab (rabies immune globulin), HyperHep (hepatitis B immune globulin) and HypRho-D (Rho (D) immune globulin). Some lots of the products have been tested and released by FDA and are not subject to the withdrawal, Miles said. The company is "in the process" of developing a manufacturing procedure for viral inactivation for its immune globulin products. Miles said the withdrawal is simply a "precautionary measure and that the firm has received no reports of hepatitis C or other viral transmissions from use of its immune globulin products...
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