ML19253C029
| ML19253C029 | |
| Person / Time | |
|---|---|
| Issue date: | 11/02/1979 |
| From: | James Keppler NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Grimes P ST. MARYS HOSP., MILWAUKEE, WI |
| References | |
| NUDOCS 7911150384 | |
| Download: ML19253C029 (2) | |
Text
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$3'! 2 1379 St. Marys Hospital License No. 48-01828-01 ATTN: Sister Priscilla Grimes Administrator 2323 North Lake Drive Milwaukee, WI 53211 Gentlemen:
During a recent inspection of Nuclear Pharmacy, Inc. of Milwaukee, it was learned that a number of hospitals in the Milwaukee area including St. Marys Hospital received unit doses of Xe-133 that were prepared from bulk material that was labeled, " Pharmaceutically Unrefined. Not tested for sterility or freedom from pyrogens. Not for human use in present form."
This matter was discussed in a telephone conversation on October 5, 1978, between Dr. Ruetz of your staff and C. J. Paperiello of our staff. At that time you were told that you would receive a list of shipments sent to you which were prepared from this material labeled " Pharmaceutical 1y Unrefined." This information is enclosed.
About half the unit dose shipments made between July 11, 1977, and January 17, 1979, were prepared in such a fashion. The remainder were prepared from bulk material obtained from FDA approved suppliers.
To our knowledge, no adverse reactions have been noted.
This information is being supplied to aid you in making medical decisions if needed.
If you have any questions on this matter do not hesitate to call Carl J. Paperiello of this office at (312) 932-2500.
Sincerely, James G. Keppler Director
Enclosure:
As stated cc w/ encl:
Central Files Reproduction Unit NRC 20b PDR NSIC bec w/ encl:
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Pap lello/km Davis N
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UNIT DOSE RECEIVED BY ST. MARYS HOSPITAL Activity Date Distributed (mci)
Prescription No.
3/29/78 11.0 13062 3/31/78 9
13161 3/31/78 11 13162 3/29/78 12 13063 3/15/78 10.50 12367 3/15/78 13.50 12368 3/15/78 11.50 12369 3/15/78 10 12370 3/15/78 10.5 12371 2/16/78 12 10862 2/16/78 11.0 10863 2/17/78 10.4 10933 2/17/78 11.70 10934 2/17/78 11.70 10945 2/17/78 13.70 10946 2/3/78 10 10135 2/3/78 10.6 10136 1/16/78 9.50 08879 1/16/78 10.1 08880 1/16/78 8.20 08881 1/17/78 10.3 08962 1/17/78 10.2 08963 1/17/78 10.70 08964 1/18/78 10.60 09040 1/18/78 9.50 09041 1/18/78 9.80 09042 1/19/78 12.00 09138 1/19/78 10.80 09139 1/19/78 10.0 09140 1/19/78 8.50 09141 1/19/78 9.50 09142 1/3/78 15.0 08114 12/29/78 12.50 07930 12/29/78 16.00 07931 12/29/78 13.80 07932 12/30/77 11.5 07988 12/30/77 12.0 07989 12/30/77 13.5 07990 12/30/77 15.0 07991 1/2/78 10.60 08032 12/13/77 12.00 07078 12/13/77 14.00 07079 12/16/77 11.6 07291 12/16/77 11.3 07292 17/16/77 10.0 07293 12/16/77 11.4 07294 12/18/78 13.70 30179 2/19/78 11.50 30208 2/19/78 12.30 30209 2/19/78 12.00 30293 2/19/78 12.60 30294 2/19/78 11.00 30295
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