D-1311-2020 Class II Terminated

Recalled by SCA Pharmaceuticals — Windsor, CT

Recall Details

Product Type
Drugs
Report Date
June 24, 2020
Initiation Date
June 16, 2020
Termination Date
March 17, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
333 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 to hospitals in PA and CA.

Code Information

Lot #: 1220017764, exp. date June 24, 2020