June 12, 2002
Wyeth Ayerst/Elkin Sinn Cherry Hill Has Recalled
Heparin Sodium Injection
- The Food and Drug Administration (FDA) released the following information.
Heparin Sodium Injection, USP, DERIVED FROM PORCINE INTESTINES, 1000 units/mL,
1 mL DOSETTE Vials, 10 mL and 30 mL Multiple Dose Vials, IV or SC use, Rx
only. Recall # D-285-2.
Packaged as: 25 x 1 mL DOSETTE Vials, 25 x 10 mL Multiple Dose Vials, and 25
x 30 mL Multiple Dose Vials.
Wyeth Ayerst/Elkin Sinn Cherry Hill, NJ, by letter on April 29, 2002.
Firm initiated recall is ongoing.
Particulates; clear crystals containing an antioxidant compound from the
vial rubber closures (stoppers).
VOLUME OF PRODUCT IN COMMERCE
0641-0391-25 -- 108,291 vials;
0641-2440-45 -- 612,058 vials;
0641-2450-45 -- 1,168,878 vials.
Nationwide and Costa Rica.