fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755...
FDA Recall #D-0193-2021 — Class II — December 17, 2020
Product Description
fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recalling Firm
SCA Pharmaceuticals — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,834 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220022977, BUD 1/20/2021; 1220023122, BUD 1/25/2021; 1220023209, BUD 1/28/2021; 1220023248, BUD 1/27/2021; 1220023319, BUD 2/1/2021; 1220023496, BUD 2/8/2021 & 1220023560, BUD 2/9/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated