Drug product
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
D-0199-2021
Product summary
- Event
- Event 86990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,880 syringes
- Official record key
drug-enforcement:D-0199-2021
Official wording
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Code information: Lot # 1220023097, BUD 1/25/2021; 1220023134, BUD 1/25/2021 & 1220023326, BUD 2/1/2021
Distribution pattern: Product was distributed to hospitals nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility