Drug product
Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012
D-0206-2021
Product summary
- Event
- Event 86990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,940 syringes
- Official record key
drug-enforcement:D-0206-2021
Official wording
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Code information: Lot # 1220022998, BUD 1/21/2021; 1220023115, BUD 1/25/2021; 1220023163, BUD 1/26/2021; 1220023186, BUD 1/27/2021; 1220023234, BUD 1/31/2021; 1220023393, BUD 2/3/2021; 1220023477, BUD 2/4/2021; 1220023568, BUD 2/9/2021 & 1220023625, BUD 2/11/2021.
Distribution pattern: Product was distributed to hospitals nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility