SafetyAlerts
November 21, 2002
Eli Lilly Has Recalled Cefuroxime
(Cefuroxime
is an antibiotic.)
The Food and Drug Administration (FDA) has released the following
information.
PRODUCT
1) Cefuroxime for Injection, USP, 1.5g, Novaplus brand,
Infusion Bottle, For Intravenous Use, Rx only, Recall # D-050-3.
2 A) Cefuroxime for Injection USP, 7.5g, Novaplus brand,
Pharmacy Bulk Package, For Intravenous Use,
Not For Direct Infusion, Rx only, Recall # D-051-3;
2 B) Cefuroxime for Injection USP, 7.5g, AmeriNet Choice brand, Pharmacy
Bulk Package, For Intravenous Use,
Not For Direct Infusion, Rx only.
3) Kefurox (Cefuroxime for Injection USP), 7.5g, Lilly brand, Pharmacy
Bulk Package, For Intravenous Use,
Not For Direct Infusion, Rx only, Recall # D-052-3.
CODE
Lot No. (Exp. date)
Cefuroxime for Injection, USP, 1.5g
W8740Y3(1-Jan-03)
Cefuroxime for Injection USP, 7.5g
F3530Y2 (1-Mar-03), Z4420Y1 (1-Apr-03), Z4460Y1 (1-Apr-03),
Z4460Y6 (1-Apr-03), F0290Y2 (1-Jan-03), F3530Y1 (1-Mar-03),
Z4430Y5 (1-May-03).
Kefurox (Cefuroxime for Injection USP), 7.5g
F0290Y3 (1-Jan-03), F3530Y3 (1-Mar-03), Z4420Y2 (1-Apr-03).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eli Lilly and Co., Indianapolis, IN, by letters on
October 7, 2002.
Manufacturer: Eli Lilly Italia, S.P.A., Sesto Fiorentino, Italy.
Firm initiated recall is ongoing.
REASON
Discoloration: product exceeded specification for color level (18 month
stability).
VOLUME OF PRODUCT IN COMMERCE
25,500 units.
DISTRIBUTION
Nationwide. |