February 6, 2002Gensia Sicor Has Recalled Hydralazine
Irvine, CA (SafetyAlerts)
- The Food and Drug Administration (FDA) said that Gensia Sicor
has recalled Hydralazine Hydrochloride Injection.
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 #
The following lots are affected:
Gensia Sicor Pharmaceuticals Inc., Irvine, CA, by letter Oct. 26, 2001 and
Dec. 17, 2001. Firm initiated recall is ongoing.
Particulate matter specification failure (visual).
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Puerto Rico.