MERCK DEVELOPING NEW STABILITY TESTS FOR PRIMAXIN, MEFOXIN

Executive Summary

MERCK DEVELOPING NEW STABILITY TESTS FOR PRIMAXIN, MEFOXIN in response to a Dec. 6 FDA warning letter which said that Merck's "failure to conduct reconstitution stability testing for these products is a significant deviation [from current Good Manufacturing Practices] and we are concerned about the absence of such data for products that are currently on the market." The warning letter from FDA's Baltimore district office followed an Oct. 27-Nov. 10, 1993 inspection of Merck's Elkton, Va. manufacturing facility. Primaxin I.V. and I.M. (imipenem/cilastatin sodium) and Mefoxin (cefoxitin sodium) are broad-spectrum injectable antibiotics.