ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only...
FDA Recall #D-0188-2021 — Class II — December 17, 2020
Product Description
ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
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
1,879 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023041, BUD 1/20/2021; 1220023188, BUD 1/27/2021 & 1220023397, BUD 2/3/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated