September 14, 1999
Timentin, Rx Sterile Injectable Antibacterial
Piscataway, NJ (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that SmithKline Beecham Pharmaceuticals is recalling
Timentin Intravenous Infusion because there is a lack of assurance of sterility.
a) Timentin Intravenous Infusion (Sterile Ticacillin
disodium and clavulanate potassium), 31 gram, 100 cc Pharmacy Bulk Package;
b) Timentin Intravenous Infusion (sterile ticarcillin disodium and clavulante
potassium), 3.1 gram, in 50 cc and 100 cc vials and 50 cc ADD-Vantage units.
Recall #D-404/405-9. Class II
NDC #0029-6571-26, 3.1 gram/50cc vial
KS3330 EXP 04/30/2000
KS3331 EXP 04/30/2000
KS3335 EXP 03/31/2000
KS3342 EXP 04/30/2000
KS3347 EXP 04/30/2000
KS3349 EXP 04/30/2000
KS3350 EXP 04/30/2000
KS3351 EXP 04/30/2000
KT3353 EXP 05/31/2000
KT3359 EXP 05/31/2000
KT3360 EXP 05/31/2000
KT3361 EXP 05/31/2000
KT3362 EXP 05/31/2000
KT3363 EXP 05/31/2000
KT3365 EXP 05/31/2000
KT3366 EXP 05/31/2000
KT3368 EXP 05/31/2000
KT3369 EXP 05/31/2000
KT3371 EXP 05/31/2000
KW3377 EXP 06/30/2000
KW3378 EXP 06/30/2000
KW3379 EXP 06/30/2000
NC3437 EXP 09/30/2000
NDC #0029-6571-21, 3.1 gram/100cc vial
KS3338 EXP 04/30/2000
KT3354 EXP 05/31/2000
ND3453 EXP 10/31/2000
NDC #0029-6579-21, 31 gram/100cc vial
KS3358 EXP 04/30/2000
KT3356 EXP 05/31/2000
KT3364 EXP 05/31/2000
ND3454 EXP 10/31/2000
NDC #0029-6571-40, 3.1 gram/50cc ADD-Vantage
NC3444 EXP 09/30/2000
SmithKline Beecham Pharmaceuticals, Piscataway, New Jersey.
Manufacturer, by letters sent May 5 and 17,1999. Firm-initiated recall ongoing.
Nationwide and international.
NDC #0029-6571-26- 819,270 bottles
NDC #0029-6571-21- 76,250 bottles
NDC #0029-6579-21- 37,330 bottles
NDC #0029-6571-40- 17,990 bottles
Firm estimated that 130,000 vials remained on market at time of recall initiation.
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