ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Onl...
FDA Recall #D-0189-2021 — Class II — December 17, 2020
Product Description
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
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
7,257 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220022996, BUD 1/21/2021; 1220023017, BUD 1/20/2021; 1220023021, BUD 1/17/2021; 1220023033, BUD 1/19/2021; 1220023146, BUD 1/26/2021; 1220023189, BUD 1/27/2021 1220023242, BUD 1/25/2021; 1220023321, BUD 2/2/2021; 1220023357 BUD 2/10/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated