(SafetyAlerts) - The FDA has released the following information.
PRODUCT
a) Zyprexa Tablets (Olanzapine), 5 mg, 60 tablet bottles,
Rx only. Recall # D-003-4;
b) Zyprexa Tablets (Olanzapine), 10 mg, 60 tablet bottles,
Rx only. Recall # D-004-4;
c) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles,
Rx only. Recall # D-005-4;
d) Zyprexa Tablets (Olanzapine), 20 mg, 60 tablet bottles,
Rx only. Recall # D-006-4.
CODE
a) Lot Number: 6AA66A;
b) Lot Numbers/Exp. Date: 6AH19A (01/05), 7AA39A (03/05),
and 7EA97A (04/05);
c) Lot Numbers/Exp. Date: 6AH35A (01/05), 6AG70A (11/04);
d) Lot Numbers: 7EC85A and 7AA79A.
RECALLING FIRM
Walsh Heartland, LLC, Paragould, AR, by telephone on August 15, 2003 and August 21, 2003.Firm initiated recall is ongoing.
MANUFACTURER--Unknown
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
547 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
a) Zyprexa Tablets (Olanzapine), 5 mg, 60 tablet bottles,
Rx only. Recall # D-003-4;
b) Zyprexa Tablets (Olanzapine), 10 mg, 60 tablet bottles,
Rx only. Recall # D-004-4;
c) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles,
Rx only. Recall # D-005-4;
d) Zyprexa Tablets (Olanzapine), 20 mg, 60 tablet bottles,
Rx only. Recall # D-006-4.
CODE
a) Lot Number: 6AA66A;
b) Lot Numbers/Exp. Date: 6AH19A (01/05), 7AA39A (03/05),
and 7EA97A (04/05);
c) Lot Numbers/Exp. Date: 6AH35A (01/05), 6AG70A (11/04);
d) Lot Numbers: 7EC85A and 7AA79A.
RECALLING FIRM
Walsh Heartland, LLC, Paragould, AR, by telephone on August 15, 2003 and August 21, 2003.Firm initiated recall is ongoing.
MANUFACTURER--Unknown
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
547 bottles.
DISTRIBUTION
Nationwide.




