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SafetyAlerts
October 10, 2002

Recall Update: Eli Lilly Recall Complete

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

PRODUCT
a) Vancocin HCl Injection (sterile vancomycin
hydrochloride, USP) IntraVenous, Equiv. to 500 mg
Vancomycin, VIAL No. 657, traypak of 25, Lyophilized,
Rx. NDC 0002-1444-25. Recall # D-424-2;
b) Vancocin HCl (sterile vancomycin hydrochloride, USP)
IntraVenous, Equiv. to 1 g Vancomycin, VIAL No. 7321,
traypak of 25, Lyophilized, Rx only. Recall # D-425-2;
c) Vancocin HCl for Injection (vancomycin hydrochloride for
injection, USP) IntraVenous, Equiv. to 10 g Vancomycin,
100 mL vials, Lyophilized, PHARMACY BULK PACKAGE NOT FOR
DIRECT INFUSION, Rx. NDC-0002-7355-01 (VIAL No. 7355).
Recall # D-426-2;
d) Vancomycin Hydrochloride for Injection, USP, Equiv. to
10 g Vancomycin, 100 mL vial, PHARMACY BULK PACKAGE, NOT
FOR DIRECT INFUSION, Rx only, Lyophilized, AmeriNet
Choice (Trademark) label, Vancomycin Hydrochloride for
Injection, USP, NDC 0002-9509-01. Recall # D-427-2.
e) NEBCIN (Tobramycin for Injection, USP) Equiv. to 1.2 g
Tobramycin, PHARMACY BULK PACKAGE NOT FOR DIRECT
INFUSION, Rx only, VIAL No. 7040, Traypak of 6.
Recall # D-428-2;
f) Tobramycin for Injection, USP, Equivalent to 1.2 g
Tobramycin, per 30mL, Multiple Dose Vial,(40 mg/mL)
traypaks of 6, Rx only, NOVAPLUS, USA Novation, the
supply company of VHA and UHC, and NOVAPLUS are
trademarks of Novation,LLC, NDC 0002-7382-16.
Recall # D-429-2.
g) Dobutrex Solution (Dobutamine Injection, USP) Equiv. to
250 mg, Dobutamine per 20 mL, Single Dose Vial, Rx, 20
mL VIAL No. 7175, For I.V. Use Only, Recall # D-430-2;
h) Dobutamine Injection, USP, Equivalent to 250 mg
Dobutamine per 20 mL, 20 mL Single Dose Vial, Rx only,
NOVAPLUS, For I.V. Use Only, USA. Recall # D-431-2;
i) GEMZAR (Gemcitabine HCl For Injection) 200 mg equivalent
to base, For I.V. use only, Sterile Single Use Vial, Rx,
VIAL 7501, NDC 0002-7501-01. Recall # D-432-2;
j) GEMZAR (Gemcitabine HCl For Injection) 1 g equivalent to
base, For I.V. use only, Sterile Single Use Vial, Rx,
VIAL No. 7502, NDC 0002-7502-01. Recall # D-433-2;
k) Dolophine Hydrochloride (Methadone Hydrochloride
Injection,USP) 10 mg per mL, Multiple Dose Vial, NDC-
0054-1218-42. Recall # D-434-2;
l) Brevital Sodium (Methohexital Sodium for Injection,
USP),500 mg, Anesthetic Barbiturate, Multiple Dose Vial,
Rx Only. Recall # D-435-2;
m) Brevital Sodium (Methohexital Sodium for Injection, USP)
2.5 g, Multiple Dose Vial, Anesthetic Barbiturate,
Rx Only. Recall # D-436-2.

CODE
Lot (Exp. Date)
Vancocin:
USA Distribution
500 mg
4MK94M (1-Aug-02) and 4MP18N (1-Oct-02)

1 gm
5MG16W (1-Apr-03), 5MA16M (1-Feb-03), 4MT59T (1-Sep-02), 4MT60M (1-Sep-02) and 4MX34M (1-Oct-02)
10gm
4MN09M (1-Sep-03), 4MH51M (1-May-03), 5MZ89M (1-Nov-04), and 5MZ89N (1-Nov-04)
Foreign Distribution:
4MP20XA (1-Oct-02), 4MP20XB (1-Oct-02), 5MA16M (1-Feb-03), 5MG16R (1-Apr-03), 5MG16U (1-Apr-03), 5MG16T (1-Apr-03), 4MX34P (1-Oct-02), 4MN09N (1-Sep-03), 4MP20P (1-Oct-02), 4MP20R (1-Oct-02), 4MP20S (1-Oct-02), 4MP20V (1-Oct-02), 4MP20W (1-Oct-02), 5MU91M (1-Nov-03), 5MX28M (1-Nov-03), 5MX28P (1-Nov-03), 4MK15N (1-Sep-02), 4MK15P (1-Sep-02), 5MG16S (1-Apr-03), 5MG16V (1-Apr-03), 4MP20Y (1-Oct-02), 4MP16P (1-Sep-02), 5NA70M (1-Nov-03), 4MP20T (1-Oct-02), 4MP20X (1-Oct-02), 4MP20U (1-Oct-02), and 4MK15R (1-Sep-02)
Nebcin:
USA Distribution
1.2 gm
4MK03M (1-Aug-03), 4MP21M (1-Sep-03), 4MT55M (1-Jan-04), 3MY51M (1-Oct-02), 3NG79M (1-Mar-03), 4MS30M (1-Sep-03), 4MT54M (1-Oct-03), 4MT55M (1-Jan-04), 4MW41M (1-Feb-04), 5MG75M (1-Jun-04), 5MH80M (1-Jun-04), 4MR25M (1-Sep-03) and 5MM86M (1-Jun-04), 5MX32M (1-Feb-04)
Foreign Distribution:
3NG79M (1-Mar-03), 4MK03M (1-Aug-03), 4MR25M (1-Sep-03), 4MW41M (1-Feb-04), 5MG75M (1-Jun-04), 5MH80M (1-Jun-04), 5MM86M (1-Jun-04), 4MT54N (1-Oct-03), 4MT55N (1-Jan-04) and 5MH80N (1-Jun-04)
Dobutrex:
USA Distribution:
5MF45P (1Apr-03), 4MY39P(1-Feb-03), 5MA94M(1-Feb-03), 5MM00M (1-Jun-03), 4MX96P (1-Jan-03) and 5MW48N (1-Oct-03)
Foreign Distribution:
4MY39N (1-Feb-03), 5MF45N (1-Apr-03), 5MX82M (1-Feb-04), 5MX82N (1-Feb-04), 5MX82P (1-Feb-04), 5MX82R (1-Feb-04), and 5MW48M (1-Oct-03)
Gemzar:
USA Distribution:
200 mg
4MS42M (1_Sep-02)
1gm
4MT36M (1-Sep-02), 4MT37M (1-Sep-02), 4MT63M (1-Oct-02), 5MC30M (1-Mar-03), 5MG22M(1-May-03) and 5NG88M (1-Mar-04)
Foreign Distribution:
4MT63M (1-Oct-02), 5MG22N (1-May-03), 4MT62M (1-Sep-02), 4MT62T (1-Sep-02), 4MT62P (1-Sep-02), 4MT62N (1-Sep-02), 4MT62S (1-Sep-02)
Brevital Sodium
USA Distribution
2.5 mg/20mL vials
5MT41M (8/1/2003)
4NF766M (6/1/2003)
500mg/50mL vials
3MN14M, 3MN14N (9/1/2002)
3MN33M, 3MN33P (10/1/2002)
3MN34P, 3MN34R, 3MN34S (10/1/2002)
3MY48M, 3MY48N, 3MY48P (11/1/2002)
4MP65M (9/1/2002)
4MA84M, 4MA84N, 4MA84P (11/1/2002)
4MF88M, 4MF88N (6/1/2003)
4MJ99M (7/1/2003)
5MP44M, 5MP44N (8/1/2003)
5MU47M, 5MU47P, 5MU47R (12/1/2003)
5MN77M, 5MN77N (10/1/2003)

Dolophine Hydrochloride
USA Distribution
10mg/mL 20 mL vial
5MP72M (Jun-03)
5MW93M (Sep-03).

RECALLING FIRM/MANUFACTURER
Eli Lilly and Co., Indianapolis, IN, by letters dated July 16, 2002. Firm initiated recall is ongoing.

REASON
Particulates and/or cracked vials.

VOLUME OF PRODUCT IN COMMERCE
Unknown

DISTRIBUTION
Nationwide and Internationally.

 
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.