PRODUCT
a) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles,
Rx only, Recall # D-118-4;
b) Zyprexa Tablets (Olanzapine), 20 mg, 60 tablet bottles,
Rx only. Recall# D-119-4.
CODE
a) Lot Number/Expiration Date: Lot 7EF27A (8/1/05),
Lot 7EF28A(8/1/05);
b) Lot Number/Expiration Date: Lot 7ED87A (7/1/05);
Lot 7EE34A (7/1/05).
RECALLING FIRM/MANUFACTURER
FPP Inc, Cincinnati, OH, by letter on February 18, 2004. FDA initiated recall is ongoing.
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
67 bottles.
DISTRIBUTION
Nationwide.
a) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles,
Rx only, Recall # D-118-4;
b) Zyprexa Tablets (Olanzapine), 20 mg, 60 tablet bottles,
Rx only. Recall# D-119-4.
CODE
a) Lot Number/Expiration Date: Lot 7EF27A (8/1/05),
Lot 7EF28A(8/1/05);
b) Lot Number/Expiration Date: Lot 7ED87A (7/1/05);
Lot 7EE34A (7/1/05).
RECALLING FIRM/MANUFACTURER
FPP Inc, Cincinnati, OH, by letter on February 18, 2004. FDA initiated recall is ongoing.
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
67 bottles.
DISTRIBUTION
Nationwide.
