D-0200-2021 Class II Terminated
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
- 7,275 syringes
Product Description
Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309
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 # 1220023034, BUD 1/19/2021; 1220023088, BUD 1/24/2021; 1220023112, BUD 1/25/2021; 1220023288, BUD 1/31/2021; 1220023323, BUD 2/2/2021; 1220023539, BUD 2/8/2021 & 1220023613, BUD 2/10/2021.