Drug product
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
D-0200-2021
Product summary
- Event
- Event 86990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,275 syringes
- Official record key
drug-enforcement:D-0200-2021
Official wording
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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.
Distribution pattern: Product was distributed to hospitals nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility