D-1495-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 19, 2020
- Initiation Date
- July 29, 2020
- Termination Date
- March 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,932 bags
Product Description
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.
Distribution Pattern
Product was distributed nationwide within the United States.
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