Document qdGp1VzzDNLVYNM5Bw1EYE2vq

THE UPJOHN KALAMAZOO, MICHIGAN 49001 TELEPHONE (616) 382-4000 COMPANY May 20, I976 OHfAfiRcReYofR ALLEN, M D Manager, FDA Liaison Domestic Pharmaceutical Medical Affairs Hearing Clerk Food and Drug Administration Room L-65 5600 Fishers Lane Rockville, Maryland 20852 Dear Sir: In compliance with the Federal Register Notice, Volume Lo, Number 51, March lL, 1975, page 11865, titled "Asbestos-form Particles in Drugs for Parenteral Injection", we are supplying the attached memo as an updated report for replacement of asbestos filters. Very truly yours, THE UPJOHN COMPANY HRA:pjc Attachment Manager, FDA Liaison c?*/ 1. J. W. Parker completed a study which showed that the amount of non-volatile residue remaining after a one liter sample of chloroform was evaporated to dryness was comparable whether the chloroform was filtered through asbestos or the Scott 5XR filter (1). A second 1/4 production size lot of S.A.S. Diurnal Penicillin Readimi-xed 500M has been manufactured and placed on stability. i a. Lot -:-~I was manufactured according to the current production procedure except for using the Scott BNR filter (contains ! Centroiex H and Centroiex P ) . ! i b Lot 42 was manufactured according to the current production procedure except for substitution of Centroiex P for Centroiex E and for using the Scott BNR filter (contains all Centroiex P ) . 'W lad