Monday, Jun. 05, 1944
Impure Drugs
Winthrop Chemical Co. of Rensselaer, N.Y. was in trouble again last week.* The Pure Food and Drug Administration claimed that the company had distributed some 22,000 packages of improperly distilled water and 73,000 ampoules of dextrose solution (which is made with distilled water) containing pyrogens (fever-producing substances), "undissolved particles" and mold. Patients showed "unusual symptoms" when a Boston hospital used some of the dextrose in spinal anesthesia. According to an Assistant U.S. Attorney one patient died, but the doctors think he would have died anyway. Winthrop called in all the offending packages long ago.
When Government lawyers told the story to the press last week, company officials cried Unfair! Hundreds of such cases, they claimed, come up every year without getting into print. It would take several quarts of the improperly distilled water to give a man a fever; the "undissolved particles" were material which had come off the ampoule glass; the mold was probably Penicillium notatum. (Winthrop makes penicillin.) Unfortunately for the company, distilled water is not supposed to contain anything but water, not even gratuitous penicillin.
In store for Winthrop Chemical Co., if the case is proved: maximum fines totaling $120,000, a lot of bad publicity.
*In January 1942 the company was fined $15,800 for "adulterated and misbranded" sulfathiazole (TIME, April 7, 1941).
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