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SafetyAlerts
May 29, 2002

Aventis Pharmaceuticals Has Recalled Drugs

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.

P
RODUCT
Claforan Sterile (cefotaxime) for injection, USP (formerly sterile
cefotaxime sodium), 500 mg IM/IV, Vial, Rx only. Recall # D-265-2.;
Claforan Sterile (cefotaxime) for injection, USP (formerly sterile
cefotaxime sodium), 1 gram IM/IV, Vial, Rx only. Recall # D-266-2;
Claforan Sterile (cefotaxime) for injection, USP (formerly sterile
cefotaxime sodium), 2 grams IM/IV, Vial, Rx only. Recall # D-267-2.

CODE
500-mg. x 10 Lot No. Exp. Date
100632 Oct-02
120416 Dec-02
120469 Dec-02
021969 Feb-03
051739 May-03
091877 Sep-03
1-gram x 50 Lot No. Exp. Date
090668 Sep-02
090686 Sep-02
090688 Sep-02
110558 Nov-02
110565 Nov-02
110567 Nov-02
120421 Dec-02
120452 Dec-02
021912 Feb-03
021910 Feb-03
021914 Feb-03
021913 Feb-03
021911 Feb-03
031902 Mar-03
031903 Mar-03
041786 Apr-03
041829 Apr-03
041858 Apr-03
061704 Jun-03
091881 Sep-03
2-gram x 10 Lot No. Exp. Date
090683 Sep-02
110551 Nov-02
041729 Apr-03
071840 Jul-03
101894 Oct-03
2-gram x 25 Lot No. Exp. Date
110627 Nov-02
031947 Mar-03
041778 Apr-03
071839 Jul-03
2-gram x 50 Lot No. Exp. Date
090679 Sep-02
110554 Nov-02
021948 Feb-03
041730 Apr-03
041791 Apr-03
041821 Apr-03
071838 Jul-03.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Pharmaceuticals, Inc., Kansas City, MO, by letter dated February 22, 2002.
Manufacturer: Patheon UK Limited, Swindon, Wiltshire SN35BZ, England.
Firm initiated recall is ongoing.

REASON
Labeling; product label declares inactive ingredients that are not contained in the product (Dextrose Hydrous, USP, Sodium Citrate Hydrous, USP and Hydrochloric Acid)

VOLUME OF PRODUCT IN COMMERCE
500-mg. - 418,200 vials;
1-gram - 1,635,450 vials;
2-gm. - 647,574 vials.

DISTRIBUTION
Nationwide.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.