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SafetyAlerts
February 6, 2002

Gensia Sicor Has Recalled Hydralazine Hydrochloride Injection

Irvine, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said that Gensia Sicor Pharmaceuticals Inc. has recalled Hydralazine Hydrochloride Injection.

PRODUCT
Hydralazine Hydrochloride Injection, USP, 20 mg/mL,
For IM or IV use, 1 mL single dose vial. This product is packed under two brand labels. Gensia Sicor (NDC 0703-8201-04) and NovaPlus (NDC 0703-8201-94), Recall #
D-103-2.

CODE
The following lots are affected:
00B119
00C116
00H113
00J105
00K111
00K118
00K128
01A125
01D113
01D118
01K107.

RECALLING FIRM/MANUFACTURER
Gensia Sicor Pharmaceuticals Inc., Irvine, CA, by letter Oct. 26, 2001 and Dec. 17, 2001. Firm initiated recall is ongoing.

REASON
Particulate matter specification failure (visual).

VOLUME OF PRODUCT IN COMMERCE
1,665,200 vials.

DISTRIBUTION
Nationwide and Puerto Rico
.

 
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.