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Safety Alerts
September 14, 1999

Timentin, Rx Sterile Injectable Antibacterial Combination Recalled

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.

Amount Shipped:
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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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.