D-0199-2021 Class II Terminated

Recalled by SCA Pharmaceuticals — Windsor, CT

Recall Details

Product Type
Drugs
Report Date
January 13, 2021
Initiation Date
December 17, 2020
Termination Date
November 2, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,880 syringes

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

Distribution Pattern

Product was distributed to hospitals nationwide.

Code Information

Lot # 1220023097, BUD 1/25/2021; 1220023134, BUD 1/25/2021 & 1220023326, BUD 2/1/2021