Drug product
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
D-1495-2020
Product summary
- Event
- Event 86194
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,932 bags
- Official record key
drug-enforcement:D-1495-2020
Official wording
Reason: Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Code information: Lot #: 1220018755, Exp. Date 7/30/2020; 1220018861, 1220018850, Exp. Date 8/4/2020; 1220018899, Exp. Date 8/5/2020; 1220019027, Exp. Date 8/11/2020; 1220019075, Exp. Date 8/12/2020; 1220019243, Exp. Date 8/20/2020; 1220019439, 1220019279, 1220019392, Exp. Date 8/24/2020; 1220019488, Exp. Date 8/26/2020
Distribution pattern: Product was distributed nationwide within the United States.
Derived failure modes
-
Potency or specification failure
Subpotent