Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic...
FDA Recall #D-0187-2021 — Class II — December 17, 2020
Product Description
Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509
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
3,793 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023305, BUD 12/17/2020; 12200223400, BUD 12/19/2020; 1220023536, BUD 12/25/2020; 1220023608, BUD 12/27/2020; 1220023811, BUD 12/26/2020 & 1220023812, BUD 12/26/2020.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated