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
FDA recall notice · announced August 19, 2020 · Sca Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Reason for recall
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Notes
Distribution: Product was distributed nationwide within the United States.
Lot/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
Quantity: 3,932 bags
Status: Terminated
Products in this recall event:
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.