ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA P...
FDA Recall #D-0213-2021 — Class II — December 17, 2020
Product Description
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409
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
9416 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023022, BUD 1/17/2021; 1220023023, BUD 1/17/2021; 1220023029, BUD 1/19/2021; 1220023030, BUD 1/20/2021; 1220023117, BUD 1/25/2021; 1220023145, BUD 1/26/2021 & 1220023166, BUD 1/27/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated