fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pha...
FDA Recall #D-0214-2021 — Class II — December 17, 2020
Product Description
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
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
6710 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot #1220023109, BUD 1/25/2021; 1220023255, BUD 1/26/2021; 1220023256. BUD 1/26/2021; 1220023257, BUD 1/28/2021; 1220023334, BUD 2/2/2021 & 1220023518, BUD 2/8/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated