Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 75...
FDA Recall #D-0190-2021 — Class II — December 17, 2020
Product Description
Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
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
952 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023042, BUD 1/21/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated