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DATE RECALL INITIATED:
November 3, 2003
LOT NUMBERS
Sterile Water for Injection (30mL vials), USP, lot numbers 02111011, 05311011, 10411011, 12111011, 13511011, 18011011, and 19211011 packaged as a component of following lots of Humate-P:
| Humate-P Lot nos. |
Sterile Water Lot Nos. |
| 19366611A, 19466611A |
02111011 |
| 19766611A, 19866611A, 19966611A, 20066611A, 20166611A, 20266611A, 20566611A, 20666611A |
05311011 |
| 20766611A, 20866611A, 21266611A, 21366611A, 21466611A, 21566611A, 21666611A, 21766611A, 22066611A |
10411011 |
| 22166611A, 22266611A, 22566611A, 22666611A, 22766611A, 22866611A, 22966611A, 23066611A, 23366611A, 23466611A, 23566611A |
12111011 |
| 23666611A, 23766611A, 23866611A, 23966611A, 24266611A, 24366611A, 24466611A, 24666611A |
13511011 |
| 24566611A, 24766611A, 25266611A, 25366611A, 25466611A, 25566611A |
18011011 |
| 26666611A |
19211011 |
MANUFACTURER:
Aventis-Behring, L.L.C.
1020 First Avenue
P.O. Box 61501
King of Prussia, PA 19406-0901
REASON:
Aventis-Behring, L.L.C., is recalling Sterile Water for Injection (30mL vials), USP, that is packaged as a component of Humate-P after discovering occurrences of cracked vials involving these lots of Sterile Water for Injection, USP. The manufacturer advises that this is not a recall of Humate-P and instructs recipients not to return any Humate-P. Instead, establishments are instructed to examine their inventories of Humate-P for vials of Sterile Water for Injection, USP, from the listed lots. Any stock of Sterile Water for Injection, USP, from the listed lots should not be used or distributed, but returned to Aventis-Behring.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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