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SafetyAlerts
February 12, 2003

Pharmacia Corporation Has Recalled Caverject

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

PRODUCT
a) Caverject (alprostadil for injection), 5 mcg, single
dose vials, Rx only, For intracavernosal use only.
NDC 0009-7212-03. Recall # D-103-3.
b) Caverject (alprostadil for injection), 10 mcg, single
dose vials, Rx only, For intracavernosal use only.
NDC-0009-3778-08. Recall # D-104-3.
c) Caverject (alprostadil for injection), 20 mcg, single
dose vials, Rx only, For intracavernosal use only.
NDC 0009-3701-01 and NDC 0009-3701-96 (Physician
samples). Recall # D-105-3.

CODE
a) Lot Expiration date
31HPU 02/2004.
b) Lot Exp. Date
08HRJ 03/2004;
20HYA 05/2004;
26HPJ 01/2004;
66HCK 08/2003;
80FPM 01/2003.
Foreign Distribution (New Zealand, Hong Kong, Singapore)
HI1577 11/2002;
IC1411 01/2003;
IF1015 04/2003.
C) 04HHP 02/2003;
06HKP 03/2003;
22HHF 01/2003;
33HPU 05/2003;
40HSU 07/2003;
54HDC 11/2002;
58HRY 06/2003;
64HCK 11/2002
66HWS 07/2003;
73JBT 10/2003;
75HDJ 11/2002;
78HFF 12/2002;
84HJT 02/2003;
86HFS 12/2002;
87HFS 12/2002;
Physician Samples:
08HMC 03/2003;
21HHF 12/2002;
57HRY 06/2003;
80HDU 11/2002.
Foreign Distribution (New Zealand, Hong Kong, and Singapore):
IA1289 12/2002;
IB0591 12/2002;
IB1100 12/2002;
IC1410 01/2003;
ID0900 03/2003;
IF0207 03/2003;
II1204 06/2003;
JC1316 01/2004;
JE0747 03/2004.

RECALLING FIRM/MANUFACTURER
Pharmacia Corporation, Kalamazoo, MI., by letters on December 2, 2002. Firm initiated recall ongoing.

REASON
Lack of assurance of sterility for the prefilled diluent syringes packaged for use with the product.

VOLUME OF PRODUCT IN COMMERCE
a) 1,623 units;
b) 35,450 units;
c) 139,081 units.

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.