Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainb...
FDA Recall #D-0199-2021 — Class II — December 17, 2020
Product Description
Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
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
1,880 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023097, BUD 1/25/2021; 1220023134, BUD 1/25/2021 & 1220023326, BUD 2/1/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated