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-1311-2020
Product summary
- Event
- Event 85865
- Status
- Terminated
- Classification
- Class II
- Quantity
- 333 bags
- Official record key
drug-enforcement:D-1311-2020
Official wording
Reason: Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Code information: Lot #: 1220017764, exp. date June 24, 2020
Distribution pattern: Product was distributed to hospitals in PA and CA.
Derived failure modes
-
Potency or specification failure
Subpotent